An FDA panel of outside experts has contributed a round of thumbs-up for Bayer's new drug for pulmonary arterial hypertension, to be sold as Adempas, sending the pharma giant on what appears to be another victory lap in the lead-up to a likely approval.
The group voted unanimously in favor of riociguat, both for PAH as well as chronic pulmonary thromboembolic hypertension. And while the FDA doesn't have to accept the recommendation, it's quite likely that it will--while weighing a recommendation from staffers to green-light a lower maximum dose than Bayer was seeking.
Bayer got a key endorsement late last week from FDA staffers, who signaled a clear appreciation for the late-stage data on the drug. "This drug is approvable so long as its dosing algorithm is modified," noted FDA reviewer Preston Dunnmon.
The staff review recommended an approval for doses ranging from 0.5 mg to 1.5 mg three times a day, lower than the 2.5-mg maximum that Bayer is seeking an approval on. But most panelists were open to the 2.5-mg maximum, reports Reuters, preferring to leave that decision to doctors who can balance efficacy against the risk of side effects.
A few months ago 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 ($UTHR) and Actelion ($ATLN) were busy working on next-gen versions of 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), recently obtained an approval for Stivarga and added an OK for Xofigo as a new therapy for advanced prostate cancer.
"If approved, riociguat will offer a new treatment option for patients with PAH and will also provide the first approved non-surgical treatment option for CTEPH patients who are inoperable or who have recurrent or persistent disease," said Pamela A. Cyrus, the head of U.S. Medical Affairs for Bayer HealthCare Pharmaceuticals. "We look forward to continued dialogue with the FDA in order to make riociguat available to patients."
- here's the story from Reuters
- here's the release from Bayer