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AstraZeneca announces FDA approval of Epanova (omega-3-carboxylic acids)

BY Michael Johnsen

WILMINGTON, Del. — AstraZeneca on Tuesday announced the Food and Drug Administration approved Epanova (omega-3-carboxylic acids) as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500 mg/dL).

"The FDA approval of Epanova is good news for the significant and growing population with severe hypertriglyceridemia as it offers physicians and their patients an important new treatment option that has been proven to be effective in clinical trials," stated Briggs Morrison, EVP global medicines development and chief medical officer, AstraZeneca. "This approval is a significant milestone for AstraZeneca, as it strengthens our existing portfolio of medicines. We are committed to further assessing the clinical profile of Epanova and identifying other patient groups it may benefit."

Epanova is the first FDA approved prescription omega-3 in free fatty acid form, AstraZeneca reported. The dosage of Epanova is 2 grams (2 capsules) or 4 grams (4 capsules), making it the first prescription omega-3 to have a dosing option as few as two capsules once a day. It can be taken with or without food.

"Patients with severe hypertriglyceridemia often have other medical conditions, such as diabetes and high blood pressure, that require them to take multiple medications," added Michael Davidson, EVP of Omthera Pharmaceuticals, an AstraZeneca company. "Although physicians will treat each patient individually, Epanova offers physicians a two-capsule dosing option, once a day with or without food. This provides physicians with a simple, patient-friendly option to effectively manage this serious condition without dramatically increasing a patient’s pill burden when prescribing the two gram dose."

 

 

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GPhA pledges support behind Affordable Medicines Caucus

BY Michael Johnsen

WASHINGTON — The Generic Pharmaceutical Association on Friday applauded the launch of the bipartisan Affordable Medicines Caucus, co-chaired by Reps. Peter Welch, D-Vt., and Keith Rothfus, R-Pa. 

“Members of both parties agree: taking full advantage of generic medicines is a common sense way to save billions of dollars for the government, and for millions of Americans,” stated Ralph Neas, president and CEO GPhA. “Indeed, an IMS health analysis released by GPhA in December 2013 showed that generic pharmaceuticals have achieved $1.2 trillion in savings over the past decade, nearly $217 billion in 2012 alone, all of which translates to more than one billion dollars in savings every other day.”

The caucus will share the latest information on the positive impact of generics on cost savings and help legislators track the latest developments in the field. “Working together,” Neas said, “we can build on the tremendous 30-year track record of bipartisan cooperation that has resulted in unprecedented access to safe, affordable and life-changing generic medicines in America and around the world.”

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Sandoz reports on six biosimilar molecules in the Phase III clinical trial/filing prep phase

BY Michael Johnsen

BASEL, Switzerland — Sandoz recently announced that the generic manufacturer continues to advance its biosimilars pipeline that currently has six molecules in the Phase III clinical trial/filing prep phase. 

For example, Sandoz completed the patient enrollment for its Phase III trial with biosimilar etanercept (Amgen’s Enbrel). The global clinical trial seeks to confirm biosimilarity with regard to safety, efficacy and immunogenicity of the Sandoz product versus Enbrel in patients with moderate to severe chronic plaque-type psoriasis. 

Sandoz also completed a Phase III trial for the U.S. registration of biosimilar filgrastim (Amgen’s Neupogen) and two global Phase III trials for global registration of biosimilar pegfilgrastim (Amgen’s Neulasta). The trials aimed to confirm biosimilarity of the Sandoz biosimilars versus Neupogen and Neulasta in breast cancer patients eligible for myelosuppresive chemotherapy treatment. Sandoz is currently preparing to file Filgrastim in the United States, and pegfilgrastim in the United States and Europe.

Sandoz also continues to make strong progress on its other biosimilar clinical development programs, which includes biosimilar versions of rituximab (Roche’s Rituxan/MabThera) and adalimumab (AbbVie’s Humira).

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