Top news of the day across the health care landscape.
Janssen Pharmaceuticals has submitted a supplemental Biologics License Application (sBLA) to the FDA for guselkumab (Tremfya) for the treatment of adults with active psoriatic arthritis, MD Magazine reported. According to the article, the submission for guselkumab is based on data from the phase 3 DISCOVER-1 and DISCOVER-2 trials, which investigated guselkumab subcutaneous injection compared with placebo. The results showed that patients treated with guselkumab achieved patient response following 24 weeks of therapy, the article reported.
An independent expert panel to the FDA recommended approval of GlaxoSmithKline’s OTC nicotine oral spray developed for smoking cessation, Reuters reported. According to the article, the spray delivers 1 milligram of nicotine and is meant to be used within recommended limits of 4 sprays per hour and a maximum of 64 sprays per day when the individual gets an urge to smoke. The panel voted 9 to 6 in favor of therapy, indicating that its benefits as a smoking cessation aid outweighed risks, the article reported.
E-cigarette use has continued to increase among US teens, The Associated Press reported. According to the article, researchers surveyed more than 42,000 students across the country in grades 8, 10, and 12. The study showed that approximately 25% of high school seniors surveyed this year said they vaped nicotine in the previous month, up from 21% the year before, whereas cigarette smoking declined from approximately 8% to 6%, the article reported.