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Bayer HealthCare receives CHMP backing for new hypertension therapy
Bayer HealthCare has announced that riociguat, its new tablet therapy for hypertension, has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP).
The committee has endorsed the drug for European approval as a means of treating adult patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or persistent or recurrent CTEPH after surgical treatment to improve exercise capacity.
It has also been recommended as a treatment for adult patients with pulmonary arterial hypertension to improve exercise capacity, with a final decision from the European Commission expected during the first half of this year.
Riociguat is the first of a novel class of drugs and has demonstrated its safety and efficacy in a series of phase III trials.
Dr Kemal Malik, member of the Bayer HealthCare executive committee and head of global development, said: "We look forward to bringing riociguat to patients with these rare, serious and life-threatening diseases upon approval of the European Commission."
This comes after the CHMP endorsed the positive overall safety profile of the company's haemophilia A treatment Kogenate Bayer last month.
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