Amgen and Pfizer Lead Pipeline NewsBy
A roundup of the latest pipeline news, including from the pharmaceutical majors, featuring news from Amgen and Pfizer
Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday May 31, 2017 to Tuesday June 6, 2017.
Amgen Submits sBLA for Anti-Cholesterol Drug Repatha
Amgen has submitted a supplemental biologics license application (sBLA) to the US Food and Drug Administration and a variation to the marketing authorization to the European Medicines Agency (EMA) for Repatha (evolocumab), a PCSK9 inhibitor and anti-cholesterol drug.
The regulatory submissions are based on the 27,564-patient Repatha cardiovascular outcomes study, which showed that maximally reducing low-density lipoprotein cholesterol (LDL-C) levels with Repatha, beyond what is possible with the current best therapy alone leads to a further reduction in major cardiovascular events, including heart attacks, strokes and coronary revascularizations.
Repatha is approved in more than 50 countries, including the US, Japan, Canada, and in all 28 countries that are members of the European Union. Applications in other countries are pending.
Repatha (evolocumab) is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Repatha binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels, according to information from Amgen.
FDA Grants Fast-Track Status to Pfizer Rare Disease Cardio Drug
The US Food and Drug Administration (FDA) s granted fast-track designation to Pfizer’s tafamidis, an investigational treatment for transthyretin cardiomyopathy (TTR-CM), a rare disease is associated with progressive heart failure and is universally fatal. Currently in Phase IIIclinical development for TTR-CM, tafamidis is being evaluated for its potential to reduce mortality and cardiovascular-related hospitalizations.
The FDA’s fast-track approach is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address an unmet medical need.