Just hours after Bayer laid out some ambitious plans to accelerate development of a new wave of cancer and cardiovascular therapies, the FDA came through with a key new approval of riociguat--to be sold as Adempas--for a devastating lung disease.
The approval comes as no great surprise. Bayer aced its panel review for the drug back in August, winning over experts as well as the staffers who handled the internal review. Adempas was also approved for thromboembolic pulmonary hypertension.
"Adempas is the first in its drug class approved to treat pulmonary hypertension and the first drug of any class to be shown to be effective for patients with CTEPH," said Norman Stockbridge, director of the Division of Cardiovascular and Renal Drug Products in the FDA's Center for Drug Evaluation and Research.
Earlier this year Bayer investigators added to the trove of late-stage data on riociguat, demonstrating its ability at helping patients improve their performance in a 6-minute walk test. The pharma company has been developing this treatment while United Therapeutics ($UTHR) and Switzerland's Actelion ($ATLN) were busy working on next-gen versions of pulmonary arterial hypertension (PAH) drugs. United, though, recently picked up its second CRL from the FDA for an oral version of Remodulin. Actelion, however, believes it is well positioned to pick up an approval on macitentan--an absolutely essential product needed to safeguard its blockbuster PAH franchise.
Thomson Reuters Pharma says that analysts have projected average sales of $679 million for riociguat by 2017. If they are right, Bayer will continue to rack up some impressive gains on the pharma side of the business. The pharma company--which has a $4 billion R&D budget--markets Nexavar with Onyx Pharmaceuticals ($ONXX) and recently obtained an approval for Stivarga as well as Xofigo as a new therapy for advanced prostate cancer.
"Bayer is deeply committed to bringing new treatment options to patients with life-threatening diseases. Adempas is an excellent example of this commitment, because it is the result of years of dedicated research in our Bayer laboratories into a new way of treating two forms of pulmonary hypertension," said Pamela Cyrus, the head of U.S. medical affairs for Bayer HealthCare Pharmaceuticals. "We are pleased to bring this new class of treatment to patients with PAH or with inoperable CTEPH or persistent/recurrent CTEPH after surgical treatment."
- here's the FDA's release
FDA experts give Bayer's riociguat unanimous backing for lung disease
FDA staffers back approval of Bayer hypertension drug
Bayer bolsters campaign for PAH drug riociguat with positive long-term data
Bayer nails promising PhIII results for new PAH contender riociguat