BRIDGEWATER, N.J. and TARRYTOWN, N.Y., April 25, 2017 /PRNewswire/ -- Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved the companies' new supplemental Biologics License Application (sBLA) for a once-monthly (every four weeks), 300 mg dose of Praluent® (alirocumab) Injection for the treatment of adults with high low-density lipoprotein (LDL) cholesterol.
Praluent is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of LDL cholesterol. The effect of Praluent on cardiovascular (CV) morbidity and mortality has not been determined.
"The FDA approval of once-monthly Praluent is encouraging news for patients with clinical ASCVD or HeFH because it enables physicians to further tailor their treatment to lower LDL cholesterol," said Robert Pordy, M.D., Vice President of Cardiovascular & Metabolism Therapeutics, Regeneron. "Selecting the most appropriate therapy based on individual patient preference is an important consideration for healthcare professionals as high cholesterol treatment often requires long-term management."
"Many patients in the U.S. continue to struggle with high levels of bad cholesterol, or LDL cholesterol, despite diet, exercise and other lipid-lowering therapies, so new dosing options are welcome additions to the treatment landscape," said Corinne Hanotin, M.D., Global Project Head, Cardiovascular Clinical Development, Sanofi. "Praluent is now the only PCSK9 inhibitor to offer two dosage strengths with two levels of efficacy, as well as a monthly dosing option."
The 300 mg dose is administered via two 150 mg injections at two different injection sites. Each 1 mL pre-filled pen delivers 150 mg of Praluent in 20 seconds or less. The European Commission (EC) also approved the monthly 300 mg dose of Praluent in November 2016.
The once-monthly dose of Praluent was approved by the FDA and the EC based on results from the Phase 3 ODYSSEY CHOICE I study, which evaluated the efficacy and safety of Praluent 300 mg every four weeks compared to placebo in patients with hypercholesterolemia who were also taking concomitant statin. In the U.S., the recommended starting dose for Praluent is 75 mg once every two weeks administered subcutaneously, or alternatively, 300 mg once every four weeks (monthly) for patients who prefer less frequent dosing. These doses can be adjusted to a maximum dose of 150 mg every two weeks for patients requiring greater LDL cholesterol reductions.
Praluent is contraindicated in patients with a history of a serious hypersensitivity reaction to Praluent. Allergic reactions have included hypersensitivity vasculitis and hypersensitivity reactions requiring hospitalization. In the ODYSSEY CHOICE I study in which all patients received an injection of Praluent or placebo every two weeks to maintain the blind, local injection site reactions were reported more frequently in patients treated with Praluent 300 mg every four weeks as compared to those receiving Praluent 75 mg every two weeks or placebo (16.6%, 9.6%, and 7.9%, respectively).
Praluent inhibits the binding of PCSK9 (proprotein convertase subtilisin/kexin type 9) to the LDL receptor and thereby increases the number of available LDL receptors on the surface of liver cells, which results in lower LDL cholesterol levels in the blood. Praluent is the only PCSK9 inhibitor available in two dosages with two levels of efficacy (75 mg and 150 mg) and now also available as a monthly dosing option (300 mg), allowing physicians to select the dose based on a patient's LDL cholesterol lowering needs.
Praluent is approved in more than 50 countries worldwide, including the U.S., Japan, Canada, Switzerland, Mexico, Brazil and the European Union (EU). In the U.S., Praluent is approved for use as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with HeFH or clinical atherosclerotic CV disease, who require additional lowering of LDL cholesterol. In the EU, Praluent is approved for the treatment of adult patients with primary hypercholesterolemia (HeFH and non-familial) or mixed dyslipidemia as an adjunct to diet: a) in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach their LDL cholesterol goals with the maximally-tolerated statin or b) alone or in combination with other lipid-lowering therapies for patients who are statin intolerant, or for whom a statin is contraindicated. The effect of Praluent on CV morbidity and mortality has not yet been determined. ODYSSEY OUTCOMES is prospectively evaluating the effect of Praluent on the occurrence of CV events in approximately 18,000 patients who have experienced an acute coronary syndrome.
Important Safety Information for the U.S.
Do not use PRALUENT if you are allergic to alirocumab or to any of the ingredients in PRALUENT. Before you start using PRALUENT, tell your healthcare provider about all your medical conditions, including allergies, and if you are pregnant or plan to become pregnant or if you are breastfeeding or plan to breastfeed.
Tell your healthcare provider or pharmacist about any prescription and over-the-counter medicines you are taking or plan to take, including natural or herbal remedies.
PRALUENT can cause serious side effects, including allergic reactions that can be severe and require treatment in a hospital. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any symptoms of an allergic reaction including a severe rash, redness, severe itching, a swollen face, or trouble breathing.
The most common side effects of PRALUENT include: redness, itching, swelling, or pain/tenderness at the injection site, symptoms of the common cold, and flu or flu-like symptoms. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Talk to your doctor about the right way to prepare and give yourself a PRALUENT injection and follow the "Instructions for Use" that comes with Praluent.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please click here for the full Prescribing Information
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
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