Piramal Pharma Solutions Supports George Medicines in Developing its New Drug for Hypertension, WIDAPLIK™ (telmisartan, amlodipine and indapamide)
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Piramal Pharma Solutions extended its robust CDMO capabilities to George Medicines to develop WIDAPLIK. - WIDAPLIK is the first and only FDA-approved triple combination medication for use as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals.
- WIDAPLIK contains three medicines that are clinically proven to reduce blood pressure: telmisartan, amlodipine, and indapamide.
WIDAPLIK is a single pill combination of three medicines, telmisartan, amlodipine, and indapamide, for the treatment of hypertension, developed in three doses (10/1.25/0.625 mg, 20/2.5/1.25 mg, and 40/5/2.5 mg strengths), including two doses that are lower than those currently available in single pill combinations. It is the first and only FDA-approved triple combination medication for use as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals. Its multi-mechanism approach and available doses are formulated to deliver the blood pressure-lowering benefits of a triple combination therapy early in the treatment pathway, with the established safety profile of its three component antihypertensive medications.
WIDAPLIK carries a Boxed Warning for fetal toxicity and should be discontinued as soon as pregnancy is detected. Please see full Prescribing Information and Important Safety Information, including Boxed Warning for WIDAPLIK here.
George Medicines and
The success of this endeavor underscores the advantages of Piramal's integrated approach to drug development. By leveraging the expertise and specialized capabilities of each facility involved in the project,
"This achievement highlights the value that
"Our strategic partnership with
IMPORTANT SAFETY INFORMATION
WARNING: WIDAPLIK™ can cause fetal harm when administered to a pregnant woman. When pregnancy is detected, discontinue WIDAPLIK as soon as possible. Drugs that act directly on the renin-angiotensin-aldosterone system can cause injury and death to the developing fetus. Talk with your doctor about other ways to lower blood pressure if you plan to become pregnant.
- Before taking WIDAPLIK, tell your doctor if you are breastfeeding or plan to breastfeed. Discuss with your doctor other ways to lower your blood pressure. Breastfeeding while taking WIDAPLIK is not recommended.
- Do not take WIDAPLIK if you make less urine because of kidney problems (anuria).
- Do not take aliskiren-containing products with WIDAPLIK if you have diabetes.
- Tell your doctor about all your medical conditions, including if you have heart problems, have gout, or have liver or kidney problems. Kidney problems may become worse in people that already have kidney disease. If you have kidney problems, you may need blood tests, and your doctor may need to lower your dose or may need to stop treatment with WIDAPLIK. During treatment with WIDAPLIK, certain people who have severe heart failure, narrowing of the artery to the kidney, or who lose too much body fluid such as with nausea, vomiting, bleeding, or trauma, may develop sudden kidney failure.
- Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other medicines to treat your high blood pressure or heart problem; water pills (diuretics); lithium; or digoxin.
- WIDAPLIK may cause serious side effects, including low blood pressure (hypotension) which may cause you to feel faint or dizzy. Vomiting and diarrhea, a low salt diet, sweating a lot, dialysis treatments, or not drinking enough fluid can also lead to low blood pressure.
- If you feel faint or dizzy, lie down and call your doctor right away. If you pass out (faint), have someone call your doctor or get medical help. Stop taking WIDAPLIK.
- If you have fluid and body salt (electrolyte) problems, tell your doctor if you experience any of the following symptoms: dry mouth, confusion, thirst, lack of energy (lethargic), weakness, drowsiness, passing very little urine or passing large amounts of urine, seizures, muscle pain/cramps, restlessness, muscle tiredness (fatigue), fast or abnormal heartbeat, nausea and vomiting, or constipation.
- People who have increased levels of uric acid in the blood may develop gout. If you already have gout, tell your doctor about worsening of your gout symptoms.
- In clinical studies, the most common side effects seen with WIDAPLIK were dizziness from low blood pressure, low blood sodium, or low blood potassium
The Important Safety Information does not include all the information needed to use WIDAPLIK safely and effectively.
For further information, please see accompanying complete Prescribing Information for WIDAPLIK.
To report SUSPECTED ADVERSE REACTIONS contact either:
- George Medicines at: safety@george-medicines.com or call 1-888-508-2083; or
- FDA at: www.fda.gov/medwatch or call 1-800-FDA-1088
About
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About
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For Investor Queries:
Gagan Borana
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About George Medicines
George Medicines is a late-stage biopharmaceutical company addressing significant unmet need in the treatment of cardiometabolic diseases with innovative single-pill combinations of existing treatments, designed for a balance of efficacy and safety, with the potential to improve patient adherence. Multi-mechanism, single-pill combinations offer the potential to bring significant improvements in clinical outcomes with cardiometabolic disorders, including hypertension, which remain among the leading causes of premature death and disability worldwide.
George Medicines is an independent spin-out company from
For more information, please visit www.george-medicines.com.
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