FDA panel gives nod to pulmonary hypertension drug

Twitter icon
Facebook icon
LinkedIn icon
e-mail icon
Google icon
 - thumbs up, approval, thumb

An FDA panel voted unanimously in favor of riociguat, an oral medication for two forms of pulmonary hypertension.

The Cardiovascular and Renal Drugs Advisory Committee reviewed the new drug application filed by Bayer HealthCare after the agency granted it priority review designation. Riociguat, (Adempas) is indicated as a treatment for pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH). Members voted 11-0 to approve the drug for each indication.

Riociguat is an oral soluble guanylate cyclase stimulator designed to improve exercise capacity on PAH patients and patients with persistent/recurrent or inoperable CTEPH. Two Phase 3 trials showed a statistically significant improvement in the six-minute walk test after 16 and 12 weeks of treatment, according to Berlin-based Bayer.

The FDA usually, but not always, follows the recommendation of its advisory panels.