A US Food and Drug Administration panel has unanimously backed approval of Bayer’s riociguat in two pulmonary hypertension indications.
The agency’s Cardiovascular and Renal Drugs Advisory Committee has recommended approval for riociguat, which will be called Adempas, for the treatment of both pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. The vote was 11-0 in favour.
The panel considered data from trials which enrolled 704 patients across two Phase III studies, both of which met their primary endpoint by demonstrating a statistically significant improvement in the six-minute walk test after 16 and 12 weeks respectively.
At the end of last week, FDA staffers had backed riociguat but at lower doses than the German group was looking for. Bayer is seeking approval of riociguat, which was under priority review at the FDA, for both indications with a starting dose of 1mg thrice-daily titrated up to a maximum dose of 2.5mg.
Specifically, the staffers had suggested that dosing should start at 0.5mg thrice-daily for PAH up to maximum of 1.5mg three times a day. For CETPH, for which there are no approved therapies, the staffers said patients with high systolic blood pressure who do not experience an adequate clinical response could be given a maximum dose of 2.5mg thrice-daily.
However, an FDA spokesperson told Pharma Times that “the CRDAC generally agreed that the drug should be approved at the doses proposed by the company”. The panellists indicated that “they wanted as many dosing options as possible for treating their patients and that clinicians should make the dosing determinations”.
Fresh filing for Eylea
The vote rounded off an excellent day for Bayer as earlier its partner Regeneron said it would be filing their eye drug Eylea (aflibercept) for US approval in diabetic macular oedema in 2013, a year early than scheduled. Bayer will submit the drug for this indication in Europe this year as well.
The move has been prompted by positive interim results from a two-year trial. Eylea was first approved in the USA in November 2011 for wet age-related macular degeneration and received an additional approval in September 2012 to treat macular oedema following central retinal vein occlusion.
