Keeping Track: Vertex’ Trikafta Speeds To US Approval; New Indications For AZ’s Farxiga, J&J’s Stelara, GSK’s Zejula

Here's your US review and approval news – a little earlier this week than usual: Vertex Pharmaceuticals Inc. received the go-ahead to launch its fourth cystic fibrosis treatment this week when the FDA cleared the triple combination therapy Trikafta for a broad indication in the orphan space. Trikafta also brought the Center for Drug Evaluation and Research’s annual novel agent approval count to 33.

The Food and Drug Administration also approved new indications for AstraZeneca PLC’s Farxiga to reduce risk of hospitalization for heart failure in diabetes patients with established cardiovascular disease or multiple risk factors, for Johnson & Johnson’s Stelara to treat ulcerative colitis, and for GlaxoSmithKline PLC’s Zejula to treat late-line ovarian cancer patients who are positive for