More November EMA/CHMP recommendations

A total of 10 new medicines have been recommended for approval at the November 2014 meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). Several of these have been covered in more detailed articles, but this is a brief on the remainder.

The orphan medicine Ofev (nintedanib), from family-owned German drug major Boehringer Ingelheim, received a positive opinion for the treatment of idiopathic pulmonary fibrosis. The benefits with Ofev are its ability to reduce the rate of deterioration of lung function measured as decline of absolute volume of Forced Vital Capacity (FVC) in patients with idiopathic pulmonary fibrosis. It is noted that demonstration of this effect in the two pivotal clinical studies showed a clear and consistent benefit in reducing the decline of FVC by approximately 94 mL/year and 125 mL/year respectively.

US biotech firm Celgene’s (Nasdaq: CELG) Otezla (apremilast) was recommended by the CHMP as new treatment options for psoriasis. Two indications are recommended: For the treatment of moderate-to-severe chronic plaque psoriasis in adult patients who failed to respond to or, who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA). Alone or in combination with disease modifying antirheumatic drugs (DMARDs), for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy.