Bayer pill gains FDA approval despite shutdown
pharmafile | October 9, 2013 | News story | Sales and Marketing | Bayer, FDA, adempas, hypertension
In the midst of the US shutdown of government agencies the FDA has managed to approve Bayer’s Adempas for patients with two forms of pulmonary hypertension.
The FDA reviewed Adempas (riociguat) under its priority review programme, which allows them to speed up its normal review time to just six months, as it believes Bayer’s treatment may offer ‘major advances’.
The pill belongs to a class of drugs called soluble guanylate cyclase stimulators that help arteries relax to increase blood flow and decrease blood pressure.
It is intended for patients with chronic thromboembolic pulmonary hypertension (CTEPH) after surgery or patients who cannot undergo surgery, to improve their ability to exercise.
Adempas is also indicated for patients with pulmonary arterial hypertension (PAH) of unknown causes, inherited or associated with connective tissue diseases, to improve their ability to exercise and to delay clinical worsening of their condition.
“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 at the FDA.
The pill will now enter a market that is currently dominated by two injectable drugs, namely: Actelion’s Tracleer, which made $1.6 billion last year, and Gilead’s Letairis, which made $410 million.
But Adempas is the only drug approved in the US for use in two types of pulmonary hypertension (WHO Group 1 and 4).
It is also the first and only FDA-approved drug therapy for persistent/recurrent CTEPH after surgical treatment or inoperable CTEPH, which may help its introduction into the crowded PAH market.
Pamela Cyrus, VP and head of US medical at Bayer HealthCare Pharmaceuticals, said: “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.
“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.”
Adempas is one of five drugs highlighted by Bayer this week as having the potential to achieve collective sales of €5.5 billion ($7.5 billion) over the next few years – Adempas alone is forecast to be worth around €500 million of that total in peak annual sales.
Bayer dodges shutdown delay
This all comes in the second week of the US shutdown, created at the beginning of October over political wrangling for the costs of ‘Obamacare’, which has seen the FDA agency put a forced pause on key services and functions, while also furloughing 6,620 of its employees.
It seems however that the German firm’s expedited review for Adempas has not been held up by the furore on Capitol Hill.
Ben Adams
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