FDA panel vote moves Innoviva close to approval for new antibiotic

While the US regulator’s scientists have given a positive opinion for Innoviva’s (Nasdaq: INVA) new antibiotic, the details appear not to have impressed investors, with shares falling 5% on Tuesday.

The US Food and Drug Administration’s advisory panel voted unanimously in favor of approving sulbactam-durlobactam for the treatment of adults with certain hospital-acquired infections.

However, scientists recommended a strong focus on capturing safety data to understand the profile of the therapy, given the relatively small study size.