FDA sets Dec. PDUFA date for Urovant rival to Astellas drug

The FDA has accepted Urovant Sciences’ filing for approval of overactive bladder prospect vibegron, teeing the biotech up to find out whether it has won approval in the final few days of 2020.

Urovant brought in the small-molecule beta-3 agonist from Merck in 2017 and went on to move it into a phase 3 study the following year. The initial readout from the study underwhelmed investors, who drove Urovant’s stock down after learning vibegron failed to outperform the generic used as an active control in the study.

Throughout the debate about the data, Urovant has maintained vibegron has the potential to be a best-in-class therapy, leading it to file for FDA approval shortly before the end of last year.

Thursday, Urovant revealed the FDA has accepted the filing for a standard review. The FDA set the PDUFA date for Dec. 26. The FDA currently plans to make a decision on whether to approve the drug without holding an advisory committee meeting. 

The FDA review will focus on data from a phase 3 that randomized about 1,500 overactive bladder patients to receive either vibegron, placebo or the generic drug tolterodine. The trial linked vibegron to statistically significant reductions in daily urge urinary incontinence episodes and how many times they urinated, as compared to placebo.

Vibegron performed numerically slightly better than tolterodine against those endpoints, too, but the lack of a clear-cut edge over the generic spooked investors. The reaction reflected the fact that Urovant will need to do more than just beat placebo to establish vibegron as a significant commercial product.

If vibegron wins FDA approval, it will compete against Astellas’ Myrbetriq. Astellas’ beta-3 agonist chalked up sales of ¥121 billion ($1.2 billion) over the first nine months of the year. Urovant thinks it can win share from the incumbent by showing vibegron acts faster and is safer and more tolerable than Myrbetriq, which carries a warning about hypertension.