Reports: Financial analysts say new cholesterol guidelines could mean lower use of still-experimental cholesterol-lowering biologics
NEW YORK — New cardiovascular health guidelines released this week could dampen the potential popularity of an up-and-coming class of cholesterol drugs, according to published reports.
Wall Street analysts, cited in news reports, said that the new American Heart Association and American College of Cardiology guidelines could result in lower uptake of an as-yet unapproved class of biologics known as PCSK9 inhibitors because they no longer establish specific cholesterol level targets as a goal and recommend broader use of statins, most of which are now available as generics, to reduce high-cholesterol risk.
One of the PCSK9 inhibitors is SAR236553/REGN727 (alirocumab), under development by Sanofi and Regeneron and currently in phase-3 clinical trials. The drugs work by targeting proprotein convertase subtilisin-kexin type 9, hence the name of the class. According to clinical trial results announced last month, alirocumab showed a significantly greater reduction in low-density lipoprotein "bad" cholesterol than ezetimibe, which Merck sells under the brand name Zetia.
FDA grants special status to GW Pharmaceuticals’ drug for rare epileptic disorder
LONDON — The Food and Drug Administration has given orphan drug designation to an experimental treatment for a rare form of epilepsy.
GW Pharmaceuticals said Friday that the FDA had granted the designation to Epidiolex for Dravet syndrome, a severe, drug-resistant form of epilepsy that begins in infancy. The drug is an oral liquid of a highly purified extract of cannabidiol, a non-psychoactive molecule derived from the cannabis plant.
The FDA grants orphan drug designation to experimental treatments for diseases that affect fewer than 200,000 people in the United States. The agency has given physicians permission to use the drug to treat 125 children with Dravet syndrome. The disease affects about 5,440 people in the United States and causes lifelong, ongoing seizures and intellectual disability.
FDA approves one-week antifungal drug made by Valeant
LAVAL, Quebec — The Food and Drug Administration has approved a new drug for fungal infections of the skin made by Valeant Pharmaceuticals International, the drug maker said Friday.
The company announced the FDA approval of Luzu (luliconazole) cream in the 1% strength for treatment of athlete’s foot, jock itch and ringworm in adults.
"We are pleased to receive FDA approval earlier than expected," Valeant chairman and CEO J. Michael Pearson said. "This is the first safe and effective product indicated for daily use over a one-week period. This will be a welcome alternative to current options that require two weeks of treatment, and we believe Luzu will position us well to address this growing, unmet need."