AstraZeneca Direct is designed to offer greater convenience

WILMINGTON, Del.--(BUSINESS WIRE)--Sep. 26, 2025-- AstraZeneca today announces the launch of AstraZeneca Direct, an online platform designed to create a simple, convenient way for eligible patients to access their prescribed medications at a transparent cash price with home delivery. AstraZeneca Direct will support people living with chronic conditions such as asthma, diabetes, heart failure and chronic kidney disease, and people seeking flu protection.

Starting October 1, 2025, eligible patients with prescriptions for AIRSUPRA^® (albuterol/budesonide) or FARXIGA^® (dapaglifozin) will be able to use AstraZeneca Direct to purchase these medicines directly for a cash price up to 70% off list price. Additionally, patients will also be able to order FLUMIST^® (Influenza Vaccine Live, Intranasal) for home delivery through the online platform.

Joris Silon, US Country President, AstraZeneca, said: "We remain deeply committed to improving accessibility, affordability, and driving innovation in healthcare and we are excited to launch AstraZeneca Direct, which will give patients a transparent cash price with the convenience of home delivery. The program complements our existing patient support services and is an important step forward in offering patients the medication they need, when and how they need it."

AstraZeneca Direct is an extension of the company’s longstanding US patient support offerings which continue unchanged for eligible patients. These programs help a significant number of eligible patients access their prescribed AstraZeneca medication at no or reduced cost.

AstraZeneca Direct can be accessed directly at AstraZenecaDirect.com starting Wednesday, October 1, 2025.

IMPORTANT SAFETY INFORMATION FOR AIRSUPRA^® (albuterol and budesonide)

• Do not use AIRSUPRA if you are allergic to albuterol, budesonide, or any of the ingredients in AIRSUPRA
• Before using AIRSUPRA, tell your healthcare provider about all your medical conditions and about all the medicines you take
• A dose of AIRSUPRA is 2 inhalations (puffs) as needed. Use AIRSUPRA exactly as your healthcare provider tells you to use it. Do not use AIRSUPRA more than 12 puffs (which equals 6 doses) within a 24-hour period
• AIRSUPRA is not to be used as a maintenance treatment for asthma. If you are currently taking medicine long-term to maintain control of asthma symptoms, you should continue to take that medicine as directed by your healthcare provider
• Do not change or stop other inhaled medicines or asthma medicines (oral or inhaled) without first talking to your healthcare provider
• Call your healthcare provider or get emergency medical care right away if your breathing problems get worse, you need to use AIRSUPRA more often than usual, or AIRSUPRA does not work as well to relieve your asthma
• AIRSUPRA can cause serious side effects, including:
  • worsening trouble breathing, coughing, and wheezing (paradoxical bronchospasm). If this happens, stop using AIRSUPRA and call your healthcare provider or get emergency medical care right away. This is more likely to happen with your first use of a new canister of medicine
  • heart problems, including faster heart rate and higher blood pressure
  • possible death in people who use too much AIRSUPRA
  • serious allergic reactions. Tell your healthcare provider or get emergency medical care right away if you have a skin rash, redness, or swelling; severe itching; swelling of the face, mouth, or tongue; trouble breathing or swallowing; or chest pain
  • changes in laboratory blood levels. Low levels of potassium (hypokalemia) may cause abnormal heart rhythms
  • weakened immune system and increased chance of getting infections
  • fungal infection in your mouth and throat (thrush). This is a common side effect. Rinse your mouth with water, if available, without swallowing after using AIRSUPRA to help reduce your chance of getting thrush
  • reduced adrenal function (adrenal insufficiency). This can happen when you start taking a medicine containing an inhaled corticosteroid (such as AIRSUPRA)
  • bone thinning or weakness (osteoporosis)
  • eye problems, including glaucoma and cataracts. Your healthcare provider may suggest having regular eye exams while using AIRSUPRA. Discuss any eye problems with your healthcare provider
• Common side effects include headache, cough, and hoarseness. These are not all the side effects of AIRSUPRA. For more information, ask your healthcare provider or pharmacist

APPROVED USE

AIRSUPRA combines 2 medicines to be used as needed as a rescue inhaler in people 18 years of age and older to:

• treat or prevent symptoms of asthma
• help prevent sudden severe breathing problems (asthma attacks)

Please see full Prescribing Information and Patient Information and discuss with your doctor.

IMPORTANT SAFETY INFORMATION FOR FARXIGA^® (dapagliflozin) 5 mg and 10 mg tablets

Who should not take FARXIGA?

Do not take FARXIGA if you are allergic to dapagliflozin or any of the ingredients in FARXIGA. Symptoms of a serious allergic reaction may include skin rash, raised red patches on your skin (hives), swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing. If you have any of these symptoms, stop taking FARXIGA and contact your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of FARXIGA?

FARXIGA may cause serious side effects including:

• Ketoacidosis. FARXIGA can cause ketoacidosis, a serious condition which may require hospitalization and lead to death. People with type 1 diabetes, type 2 diabetes, or pancreas problems have a high risk of getting ketoacidosis. Signs and symptoms may include nausea, tiredness, vomiting, trouble breathing, abdominal pain, and ketones in your urine or blood. If you get any of these symptoms, stop taking FARXIGA and call your healthcare provider right away. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL
• Dehydration (the loss of body water and salt), which may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). There have been reports of sudden kidney injury in people with type 2 diabetes who are taking FARXIGA. You may be at a higher risk of dehydration if you take medicines to lower your blood pressure, including water pills (diuretics); are age 65 or older; are on a low salt diet, or have kidney problems. Talk to your healthcare provider about what you can do to prevent dehydration including how much fluid you should drink on a daily basis. Call your healthcare provider right away if you reduce the amount of food or liquid you drink, or if you experience vomiting or diarrhea
• Serious urinary tract infections (UTI),some that leadto hospitalization, occurred in people taking FARXIGA. Tell your healthcare provider if you have any signs or symptoms of UTI including a burning feeling when passing urine, a need to urinate often, the need to urinate right away, pain in the lower part of your stomach (pelvis), or blood in the urine with or without fever, back pain, nausea, or vomiting
• Low blood sugar (hypoglycemia) can occur if you take FARXIGA with another medicine that can cause low blood sugar, such as sulfonylureas or insulin. Symptoms of low blood sugar include shaking, sweating, fast heartbeat, dizziness, hunger, headache, and irritability. Follow your healthcare provider's instructions for treating low blood sugar
• Bacterial infections under the skin of the genitals and areas around them. Rare but serious infections that cause severe tissue damage under the skin of the genitals and areas around them have happened with FARXIGA. This infection has happened in women and men and may lead to hospitalization, surgeries, and death. Seek medical attention immediately if you have fever or you are feeling very weak, tired or uncomfortable and you also develop any pain or tenderness, swelling, or redness of the skin in the genitals and areas around them
• Vaginal yeast infections in women who take FARXIGA. Talk to your healthcare provider if you experience vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), or vaginal itching
• Yeast infection of skin around the penis (balanitis) in men who take FARXIGA. Talk to your healthcare provider if you experience redness, itching, or swelling of the penis; rash of the penis; foul smelling discharge from the penis; or pain in the skin around the penis. Certain uncircumcised men may have swelling of the penis that makes it difficult to pull back the skin around the tip of the penis

The most common side effects of FARXIGA include yeast infections of the vagina or penis, and changes in urination, including urgent need to urinate more often, in larger amounts, or at night.

What should I tell my healthcare provider before taking FARXIGA?

Before you take FARXIGA, tell your healthcare provider:

• all of your medical conditions, including problems with your liver or pancreas
• if you have had diabetic ketoacidosis
• if you have type 1 diabetes, decrease in your insulin dose, serious infection, history of infection of the vagina or penis, history of urinary tract infections, or problems with urination
• if you are on a low sodium diet, going to have surgery, eating less or change in diet, dehydrated, or binge drink
• if you are pregnant, or plan to become pregnant. FARXIGA may harm your unborn baby
• if you are breastfeeding, or plan to breastfeed. It is unknown if FARXIGA passes into your breast milk
• about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements

Approved Uses for FARXIGA^® (dapagliflozin)

What is FARXIGA?

FARXIGA is a prescription medicine used to:

• improve blood sugar control along with diet and exercise in adults and children who are 10 years of age and older with type 2 diabetes
• reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and known cardiovascular disease or multiple cardiovascular risk factors
• reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure, when the heart cannot pump enough blood to the rest of your body
• reduce the risk of further worsening of your kidney disease, end-stage kidney disease, death due to cardiovascular disease, and hospitalization for heart failure in adults with chronic kidney disease

FARXIGA is not for use to improve blood sugar (glucose) control in people with type 1 diabetes.

FARXIGA is not for use to improve blood sugar (glucose) control in people with type 2 diabetes who have moderate to severe kidney problems, because it may not work.

FARXIGA is not for people with certain genetic forms of polycystic kidney disease, or who are taking or have recently received immunosuppressive therapy to treat kidney disease. FARXIGA is not expected to work if you have these conditions.

Please see Prescribing Information and Medication Guide for FARXIGA.

IMPORTANT SAFETY INFORMATION FOR FLUMIST^® (Influenza Vaccine Live, Intranasal)

• You should not get FLUMIST if you have a severe allergy to its components, eggs or other flu vaccines; or are 2 through 17 years old and take aspirin or medicines containing aspirin - children or adolescents should not be given aspirin for 4 weeks after getting FLUMIST unless your healthcare provider tells you otherwise
• Children under 2 years old have an increased risk of wheezing (difficulty with breathing) after getting FLUMIST
• Before getting FLUMIST, tell your healthcare provider about all your medical conditions, including if you: are currently wheezing; have a history of wheezing and are under 5 years of age; have asthma; have had Guillain-Barré syndrome (severe muscle weakness); have a weakened immune system or live with someone who has a severely weakened immune system; have problems with your heart, kidneys, or lungs; have diabetes; are pregnant or nursing; or are taking antiviral drugs for the treatment of influenza
• FLUMIST may cause rare but serious side effects including allergic reactions. Seek medical help right away if you experience any allergic reactions, including: hives; swelling of the face, lips, eyes, tongue or throat; throat tightness or trouble breathing
• The most common side effects are runny or stuffy nose, sore throat, and fever over 100 °F

APPROVED USE

FLUMIST is a vaccine that is sprayed into the nose to help protect against influenza in people ages 2 through 49 years. FLUMIST may not prevent influenza in everyone who gets vaccinated.

Please see full Prescribing Information, including Patient Information and Instructions for Use.

You may report side effects related to AstraZeneca products.

Notes

About AIRSUPRA

AIRSUPRA^® (albuterol and budesonide), formerly known as PT027, is a first-in-class SABA/ICS rescue treatment for asthma in the US, to be taken as needed. It is an inhaled, fixed-dose combination rescue medication containing albuterol (also known as salbutamol), a SABA, and budesonide, a corticosteroid, and has been developed in a pMDI using AstraZeneca’s Aerospheredelivery technology.

The FDA approval of AIRSUPRA was based on MANDALA and DENALI Phase III trials (Approval press release). In MANDALA, AIRSUPRA significantly reduced the risk of severe exacerbations compared to albuterol in patients with moderate-to-severe asthma when used as an as-needed rescue medication in response to symptoms. For patients treated with AIRSUPRA 180 mcg/160 mcg the annualized total systemic corticosteroids dose when compared with albuterol 180 mcg was statistically significantly different, with a reduction in mean annualized dose of 40 mg per patient. In DENALI, AIRSUPRA significantly improved lung function compared to the individual components albuterol and budesonide in patients with mild to moderate asthma.

About FARXIGA

FARXIGA^® (dapagliflozin) in the US and marketed as Forxiga in the rest of world, is a first-in-class, oral, once-daily sodium-glucose cotransporter 2 (SGLT2) inhibitor. As of June 2024, FARXIGA was approved in 126 countries as an adjunct to diet and exercise to improve glycemic control in adults with T2D. FARXIGA is approved for pediatric patients aged 10 years and above with T2D in the EU and other countries based on the T2GO trial.^1,2

In addition, FARXIGA is approved for the treatment of heart failure across the full ventricular ejection fraction range (HFrEF and HFpEF) and CKD in adult patients in more than 100 countries around the world. FARXIGA was the first heart failure medication to demonstrate mortality benefit across the full ejection fraction range.³

About FLUMIST

FLUMIST^®(Influenza Vaccine Live, Intranasal) is a live attenuated influenza vaccine (LAIV), which is administered as a nasal spray for the prevention of influenza.⁴ FLUMIST is an Advisory Committee on Immunization Practices (ACIP) and American Academy of Pediatrics (AAP)-recommended influenza vaccine option.^5,6 FLUMIST was originally approved in the US in 2003 and since then almost 200 million doses have been distributed around the world.^7,8

FluMist Home State Availability

Pharmacy laws vary state-by-state. For the 2025-2026 flu season, FluMist Home will be available in the following states: AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, MA, MD, ME, MI, MT, NC, ND, NE, NH, NJ, NV, OH, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY. For the 2025-2026 flu season. FluMist Home will not be available in: AK, AR, DC, DE, HI, IN, KS, KY, LA, MN, MO, MS, NM, NY, OK, RI, and WV. Our aim is to have this service available in all 48 contiguous states in future seasons.

Human Factors Usability Study for FluMist Self-Administration

FLUMIST for self- or caregiver-administration was approved by the FDA in September 2024, following research demonstrating that individuals over 18 years of age can safely and effectively self-administer or administer FLUMIST to eligible individuals. In FDA-required human factors/usability studies, AstraZeneca evaluated if individuals 18 through 49 years of age could appropriately administer FLUMIST when given instructions for use. The results showed that 100% of intended users successfully administered a full dose.⁹ In addition, data show that efficacy, immunogenicity and adverse events with self-administration of FLUMIST are similar to those seen with HCP-administered vaccination.¹⁰ The FLUMIST label has been updated to provide additional instructions on self and caregiver administration for eligible patients. Children 2-8 years of age with an uncertain vaccination history may not be eligible for caregiver administration and should consult their healthcare provider for further information.⁴

AstraZeneca in Respiratory & Immunology

Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals, is a key disease area and growth driver to the Company.

AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases. The Company is committed to addressing the vast unmet needs of these chronic, often debilitating, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets. Our ambition is to deliver life-changing medicines that help eliminate COPD as a leading cause of death, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases.

AstraZeneca in CVRM

Cardiovascular, Renal and Metabolism (CVRM), part of BioPharmaceuticals, forms one of AstraZeneca’s main disease areas and is a key growth driver for the Company. By following the science to understand more clearly the underlying links between the heart, kidneys, liver and pancreas, AstraZeneca is investing in a portfolio of medicines for organ protection by slowing or stopping disease progression, and ultimately paving the way towards regenerative therapies. The Company’s ambition is to improve and save the lives of millions of people, by better understanding the interconnections between CVRM diseases and targeting the mechanisms that drive them, so we can detect, diagnose and treat people earlier and more effectively.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca's innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit www.astrazeneca-us.com and follow the Company on social media @AstraZeneca.

References

1. European Medicines Agency (EMA) [Internet]. Forxiga 5mg/ 10mg film-coated tablets - Summary of product characteristics. https://www.ema.europa.eu/en/documents/product-information/forxiga-epar-product-information_en.pdf. [Last accessed: 23 September, 2025].
2. Clinicaltrials.gov [Internet]. Study to Evaluate Safety and Efficacy of Dapagliflozin in Patients With Type 2 Diabetes Mellitus Aged 10-24 Years. https://classic.clinicaltrials.gov/ct2/show/results/NCT02725593. [Last accessed: 23 September, 2025].
3. Jhund P, et al. Dapagliflozin across the range of ejection fraction in patients with heart failure: a patient-level, pooled meta-analysis of DAPA-HF and DELIVER. Nat Med. 2022; 28(9):1956-1964.
4. FLUMIST^® (Influenza Vaccine Live, Intranasal) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2025.
5. Grohskopf LA, Ferdinands JM, Blanton LH, Broder KR, Loehr J. Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices — United States, 2024–25 influenza season. MMWR Recomm Rep. 2024;73(5):1–25.
6. Recommendations for Prevention and Control of Influenza in Children, 2025–2026: Policy Statement. Pediatrics. 2025. https://doi.org/10.1542/peds.2025-073620
7. US Food and Drug Administration (FDA). FDA approves nasal spray influenza vaccine for self- or caregiver administration. https://www.fda.gov/news-events/press-announcements/fda-approves-nasal-spray-influenza-vaccine-self-or-caregiver-administration. [Last accessed: 23 September, 2025].
8. AstraZeneca. FluMist approved for self-administration in the US. https://www.astrazeneca.com/media-centre/press-releases/2024/flumist-approved-for-self-administration-in-the-us.html. [Last accessed: 23 September, 2025].
9. Bandell A, et al. The role of human factors engineering in the FDA approval process for self-/caregiver-administration of live attenuated influenza vaccine. Presented at: National Immunization Conference, August 12-14, 2024, Atlanta, GA, USA.
10. Burgess TH, et al. Self-administration of intranasal influenza vaccine: immunogenicity and volunteer acceptance. Vaccine. 2015;33(32):3894-3899.doi: 10.1016/j.vaccine.2015.06.061

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