- The European Medicines Agency's advisory group CHMP has adopted positive opinions backing labeling updates/new indications of the following drugs:
- Johnson & Johnson's (NYSE:JNJ) Invokana (canagliflozin): Study data on renal events added to labeling.
- AstraZeneca's (NYSE:AZN) Lynparza (olaparib): New indication as monotherapy for the maintenance treatment of adults with metastatic adenocarcinoma of the pancreas with germline BRCA1/2 mutations who have not progressed after at least 16 weeks on first-line chemo.
- Boehringer Ingelheim's Ofev (nintedanib): New indication for adults with other chronic fibrosing interstitial lung diseases with a progressive phenotype.
- Merck's (NYSE:MRK) Sivextro (tedizolid phosphate): Expansion of eligible patients down to 12 years old with acute bacterial skin and skin structure infections (currently approved for adults).
- Eli Lilly's (NYSE:LLY) Taltz (ixekizumab): New indication for pediatric plaque psoriasis in children as young as six years old weighing at least 25 kg and adolescents who are candidates for systemic therapy.
- Premarket: JNJ up a fraction, AZN (+4%), MRK up a fraction, LLY (+1%).