The Cardiovascular and Renal Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) recently provided a positive opinion on the approval of Bayer’s (BAYRY - Free Report) riociguat in two forms of pulmonary hypertension.
The Committee’s vote was unanimously in favour (11 vs. 0) of the candidate’s approval for the treatment of pulmonary arterial hypertension (PAH) as well as for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH). We note that Bayer had submitted a New Drug Application (NDA) for riociguat in both these indications in Feb 2013.
The regulatory submission of riociguat was based on the basis of positive results from the placebo-controlled pivotal, global phase III CHEST-1 and PATENT-1 studies.
Results from the CHEST-1 study revealed that after 16 weeks, riociguat showed a statistically significant improvement from baseline in the six-minute walk test compared to placebo. Riociguat was also well tolerated during the study.
Bayer enrolled patients suffering from naïve symptomatic PAH as well as those pre-treated with endothelin receptor antagonists (ERAs) or non-intravenous prostanoid monotherapy, for the PATENT-1 study. The study showed a statistically significant improvement in the six-minute walk test from base line after 12 weeks compared to placebo. Bayer published results from both the studies in the New England Journal of Medicine (NEJM) in Jul 2013.
The FDA is currently reviewing the NDA on a priority basis. Though the FDA is not bound to follow the advisory body’s recommendation, it generally does so. Bayer has also submitted a regulatory application for the CTEPH indication of riociguat, in Japan.
Riociguat is expected to face stiff competition in the PAH market on approval. The market already has companies like United Therapeutics Corporation (UTHR - Free Report) and Actelion Ltd. .
Bayer, a large cap pharma stock, presently carries a Zacks Rank #3 (Hold). However, another large cap pharma stock, Johnson & Johnson (JNJ - Free Report) , currently looks better positioned with a Zacks Rank #2 (Buy).