FDA panel recommends Bayer’s lung drug, but not Otsuka’s rare kidney drug
The US FDA’s Cardiovascular and Renal Drugs Advisory Committee has decided to recommend approval of Bayer’s lung drug, but not Otsuka’s rare kidney disease drug.
The panel voted unanimously 11-0 that the FDA should approve Bayer’s pulmonary hypertension drug, ricociguat. Briefing documents released ahead of the Committee meeting on the 6th August showed that medical reviewers were also in favour of recommending this drug, but had concerns over the maximum dosing limit. However, the panel decided to leave the dosing, saying they wanted as many options as possible.
If Bayer’s drug is approved, ricociguat will be sold under the brand name of Adempas, and analysts are already estimating it will generate sales of over $600 million.
However, the Cardiovascular and Renal Drugs Advisory Committee declined to endorse an expanded indication for Otsuka’s Samsca (tolvaptan) to treat autosomal dominant polycystic kidney disease (ADPKD). The panel voted 9-6 against recommending approval of this rare disease drug, citing that it was difficult to judge efficacy of the drug due to missing clinical trial data.
Tolvaptan was previously approved in 2009 to treat low serum sodium levels. Otsuka are currently seeking to expand this approval to treat patients with ADPKD as at the moment there are no approved products for slowing the progression of kidney disease in these patients. The FDA granted orphan drug status for tolvaptan in April 2012 for that indication.
The US regulatory body is proposing that Otsuka provide a Risk Evaluation and Mitigation Strategy (REMS) that includes provider and pharmacy certification and monthly patient monitoring for the first 18 months of treatment.
The FDA is not obliged to follow its advisory panel’s recommendations, but usually does.
FDA Panel Vetoes New Tolvaptan Indication (MedPage Today)
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