Welcome to your Regulatory Index News update today. An FDA advisory panel backing, expanded EU scope and impressive trial data makes for an interesting read.
US panel backs Pfizer's Xeljanz in ulcerative colitis
The FDA’s Gastrointestinal (GI) Advisory Committee have unanimously voted to back the approval of Xeljanz in ulcerative colitis as well as recommending approval for the higher 10mg dose. This comes despite the FDA concerns regarding the larger dose’s safety and may be the deciding recommendation that leads to the approval of a broader label than expected. The higher dose was previously discontinued for other Xeljanz indications, rheumatoid arthritis and psoriatic arthritis, but has made a return for difficult-to-treat patients as ulcerative colitis is known to be tough to beat. The subsequent approval decision is now in the hands of the FDA to decide. Please click here for a FiercePharma article, where you can read more.
Expanded EU scope for GSK/Innoviva’s inhaler
The European Commission has approved GlaxoSmithKline/Innoviva’s Relvar Ellipta for an expanded scope. The once-daily inhaled corticosteroid (ICS) / long-acting β2-agonist (LABA) combination will now be able to be used in patients whose asthma is already adequately controlled on these medications. This decision was based on a non-inferiority lung function study which showed patients with adequately controlled asthma were able to switch from the twice-daily Seretide Accuhaler to the once-daily Relvar Ellipta without compromising lung function. This evidence is believed to give doctors more confidence that the once-daily Relvar Ellipta has a comparable benefit and safety profile. Please click here to read more from a PharmaTimes article.
Sanofi and Regeneron find success in major cholesterol trial
Praluent, Sanofi’s and Regeneron’s cholesterol drug, has yielded strong study data that the drug significantly reduces the risk of major adverse cardiac events in high-risk patients. The 3-year study results showed a 15% reduction in the risk of death in 18,000 high-risk patients who had uncontrolled cholesterol despite taking the maximum dose of statins such as Lipitor. This has been deemed a landmark in cardiology, marking the first time since statins that a cholesterol-lowering drug significantly affected whether a patient lived or died. The manufacturers now plan to extend access to the drug through discounts to payers, in hope that they may ease up on restrictions when approving prescriptions. If you would like to read more, please click here for an article from STAT.