Advisors to the US Food and Drug Administration have recommended approval for Forest Laboratories and Almirall’s chronic obstructive pulmonary disease drug aclidinium bromide.
The agency’s Pulmonary-Allergy Drugs Advisory Committee has voted 12-2 in favour of aclidinium for the maintenance treatment of COPD. The drug is a long-acting antimuscarinic which was developed by the Spanish firm and then licensed to Forest.
The committee was also asked to evaluate if the efficacy and safety of the 400 mug twice daily dose had been adequately demonstrated. The members voted unanimously in favour of efficacy and 10 to 3 (one abstained) on the safety question.
However, a number of panellists were concerned enough to recommend a post-marketing study for aclidinium, to determine the risk of cardiovascular side effects. Forest and Almirall said they anticipated receiving FDA feedback on the filing in the second quarter of this year and if approved, Forest will sell the drug as Tudorza Pressair.
The drug will challenge Boehringer Ingelheim’s blockbuster Spiriva (tiotropium), which is marketed by Pfizer and is also a long-acting antimuscarinic. Analysts believe it could have sales of $150-$200 million.
FDA panel backs Chelsea’s Northera
Meantime, another FDA panel, its Cardiovascular and Renal Drugs Advisory Committee voted 7-4 (with one abstention and one non-vote) to recommend approval of Chelsea Therapeutics’ Northera (droxidopa). The treatment is for symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure (Parkinson’s disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.
The recommendation surprised observers seeing as how earlier this week, FDA staffers had cast doubts on the drug. They had noted that Northera has been associated with reports of a life-threatening neurological disorder known as neuroleptic malignant syndrome, but the CRDAC has decided the benefits outweigh the risks because there are few treatments available for NOH.
Northera is available in Japan where it is marketed by Dainippon Sumitomo Pharma Co and generates annual revenues of $50 million.
