An FDA advisory committee weighed in on Sanofi/Regeneron’s new cholesterol-lowering treatment and PCSK9 inhibitor, Praluent, voting 13-3 to recommend it for approval. The FDA is not required to follow the panel’s recommendation but often does. However, panelists cautioned that the drug should be limited to high-risk groups of patients, namely, those with familial hypercholesterolemia—a rare inherited condition characterized by the presence of very high levels of cholesterol in the blood, according to The Wall Street Journal. Amgen’s PCSK9 inhibitor, Repatha, will also face an FDA advisory committee Wednesday to discuss whether the drug should be recommended for approval.
Merck and its partner Samsung Bioepis announced top-line results for Phase-III trials investigating their biosimilar versions of two rheumatoid-arthritis products: Amgen’s Enbrel and Johnson & Johnson’s Remicade. The companies stated that the trials met their primary endpoints—demonstrating that they are equivalent to the original medicines in patients with moderate to severe RA. Separately, new clinical data shows that patients with RA and ankylosing spondylitis can be switched from original brand medicines to biosimilars, according to Reuters. The independent Finnish study found that patients with the two conditions saw comparable effectiveness and safety after switching from branded Remicade to a biosimilar copy of the drug.
The FDA responded to a lawsuit levied against the agency by drugmaker Amarin, saying it had no objection to data Amarin shares with healthcare providers, as long it is sufficiently supported. The lawsuit alleged that the FDA violated the company’s right to free speech by not allowing it to share certain information about its fish oil drug Vascepa. The FDA responded in a letter filed with a US District Court judge in New York by saying it has no problem with the drugmaker sharing information published in medical journals or supported by clinical trials it has conducted, according to The Wall Street Journal’s Pharmalot blog.
The American Medical Association introduced five new resolutions aimed at curtailing the rising prices of generic medicines at its annual meeting, according to MedPage Today. An AMA executive told attendees that sticker shock lowers medical compliance. The group hopes to seek help from the FDA, FTC and Generic Pharmaceutical Association to encourage methods that increase choice and competition among generic drugs.
Bayer agreed to sell its diabetes care unit to Panasonic Healthcare for $1.15 billion. Bayer’s diabetes care unit includes its blood glucose monitoring business. Some of the unit’s brands are Contour, Breeze, Elite and Microlet. Bayer had also sought a buyer for the same business in 2012 and recently renewed its efforts to sell the unit, according to Reuters.
