Regulators in the USA have given the green light to a new chronic obstructive pulmonary disease drug, Forest Laboratories and Almirall's Tudorza Pressair.
The US Food and Drug Administration has approved Tudorza Pressair (aclidinium bromide) for the long-term maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema. The thumbs-up was expected given that the agency's Pulmonary-Allergy Drugs Advisory Committee voted 12-2 in February in favour of the long-acting antimuscarinic agent which was developed by the Spanish firm and then licensed to Forest back in 2005.
The committee was also asked to evaluate if the efficacy and safety of the 400 mcg 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.
Forest chief executive Howard Solomon said that "as the first long-acting inhaled anticholinergic agent approved in over eight years for COPD, Tudorza will be an important treatment option". He added that the approval "marks an important milestone in our ongoing partnership with Almirall and advances Forest’s respiratory franchise".
Forest expects Tudorza to be available to US wholesalers in the fourth quarter of 2012. The drug got a positive recommendation from regulators in Europe two months ago, where it will be sold as Eklira and Bretaris.
The drug will challenge Boehringer Ingelheim's blockbuster Spiriva (tiotropium), which is marketed in the USA along with by Pfizer and is also a long-acting antimuscarinic.
Boehringer inflammation deal with Funxional
Meantime, Boehringer is acquiring an anti-inflammatory from privately-held UK firm Funxional Therapeutics which could be a treatment for asthma and COPD.
Under the terms of the deal, the financial details for which have not been disclosed, Boehringer is acquiring the global rights to the Cambridge-based group's FX125L compound and somatotaxin programme. The drug was recently studied in a Phase II trial.