Good news flowed in at Bayer (BAYRY) with the U.S. Food and Drug Administration (:FDA) approving the company’s Adempas tablets (riociguat). The drug is approved in the U.S. for the treatment of adults suffering from persistent/recurrent chronic thromboembolic pulmonary hypertension (:CTEPH) following surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class.
The drug is also approved for the treatment of adults suffering from pulmonary arterial hypertension (:PAH) to improve exercise capacity, improve WHO functional as well as delay clinical worsening. Adempas is already approved in Canada for the CTEPH indication.
Last month, the U.S. regulatory body granted two separate orphan drug designations to Adempas for the treatment of PAH as well as CTEPH.
Bayer mentioned in its press release that Adempas is now the only approved drug in the U.S. for the treatment of two types of pulmonary hypertension. The drug is also the only U.S. approved treatment for CTEPH that is inoperable or persistent/recurrent after surgical treatment.
Adempas’ approval in the U.S. was based on positive results from two global phase III studies - CHEST-1 and PATENT-1. Both studies met their primary objectives. Riociguat was generally well tolerated in patients suffering from PAH and CTEPH in both these studies with no unexpected adverse effects being reported. We remind investors that Bayer is also seeking EU and Japanese approval of the drug.
We believe the Adempas approval in the U.S. and EU will strengthen Bayer’s cardiovascular portfolio. However, the pulmonary hypertension market looks extremely competitive with the presence of companies like Actelion Ltd. (ALIOF) and Gilead Sciences Inc. (GILD).
We are encouraged by the string of good news coming from Bayer’s HealthCare segment in recent times. We expect the segment to continue to drive growth at the company in the coming years.
Bayer, a large-cap pharma company, presently carries a Zacks Rank #2 (Buy). Meanwhile, Roche (RHHBY) looks more attractive in the large-cap pharma space with a Zacks Rank #1 (Strong Buy).