FDA’s new and supplemental approvals in January

In the first month of the year, FDA approved four new medicines and expanded the labels of seven previously approved therapies. The new product approvals included a non-opioid pain therapy, a new acute migraine treatment, and a TROP2 antibody-drug conjugate for breast cancer.

Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) entered a new commercial territory with the approval of Journavx suzetrigine, a Nav1.8 inhibitor, for the broad indication of moderate-to-severe acute pain, a space that spans retail pharmacies and in-patient hospital settings and is dominated by generics — quite different from its commercial expertise in cystic fibrosis. The company is positioning the therapy as a measure that can be taken when NSAIDs and acetaminophen aren’t enough, and before turning to opioids. ...