AbbVie nabs pediatric OK for hep C drug Mavyret; Glenmark launches cheaper SGLT2 inhibitor in India
→ Building off a surprise success with Mavyret in adults, AbbVie has nabbed an FDA approval to market the hepatitis C drug for children ages 12 to 17. The drug — a combination of glecaprevir and pibrentasvir — racked up $3.438 billion in net revenue for 2018, far exceeding peak sales expectations. The OK was based on a trial of 47 HCV patients with genotypes 1-4 suggesting a 100% cure rate, though it covers all six genotypes.
→ India’s Glenmark on Tuesday launched a new SGLT2 inhibitor called Remogliflozin. It is the first-ever launch of the diabetes drug, which was partly developed by GSK, and it will be sold in India. SGLT2 inhibitors, such as Forxiga, Invokana and Jardiance, work by preventing the kidneys from reabsorbing glucose back into the blood. Remogliflozin, which has shown to be comparably efficacious and safe as Forxiga in a late-stage head-to-head study, will be sold at a price of 25 rupees (36 cents) per day, a discount of more than 50% to existing SGLT2 inhibitors on the Indian market, a company spokesperson told Endpoints News.
→ A day after the FDA added boxed warnings to zolpidem and other insomnia medicines for seeming to cause dangerous behaviors, Eisai is going all in on a sleep-wake regulation agent that it says compares favorably to zolpidem. The Japanese company was collaborating with Purdue Pharma on lemborexant, but now says it will buy out all worldwide development and commercialization rights. “Purdue’s business priorities have shifted since this collaboration was initiated,” CEO Craig Landau said, adding they will now focus on oncology, non-opioid pain and other CNS programs. Other potential indications include irregular sleep-wake rhythm disorder in patients with Alzheimer’s Disease.
→ We finally know exactly how many jobs Merrimack Pharma’s $MACK latest program termination cost. In an SEC filing, the company said 13 staffers now remain, around half of the 27 who survived the last round of layoffs in November. A few weeks ago Merrimack announced it was abandoning its experimental drug, MM-310, after an early-stage study involving patients with solid tumors showed that treatment with the drug was cumulatively toxic to patients, despite trial protocol amendments. Its pipeline now consists of two preclinical programs.
→ As Motif Bio works to resolve the FDA’s concerns about the safety of iclaprim, it’s doubling down on the antibiotic with a new combo program that broadens its application beyond skin infections. The UK biotech is partnering up with Scotland’s Lamellar Biomedical to test iclaprim alongside LMS-611 for cystic fibrosis lung infections. Motif Bio says the two drugs have been granted orphan designation for Staphylococcus aureus pneumonia in patients with CF in the US and Europe, respectively.
Natalie Grover contributed reporting.