The latest set of opinions from advisors to the European Medicines Agency has seen two new medicines recommended for approval.
The agency’s Committee for Human Medicinal Products (CHMP) has issued a positive recommendation on Opsumit (macitentan), Actelion’s new treatment for pulmonary arterial hypertension. The drug, which was approved by the US Food and Drug Administration earlier this month, is the follow-up to the Swiss biotech’s blockbuster Tracleer (bosentan), which goes off-patent in 2015.
The Committee has also backed Lundbeck’s Brintellix (vortioxetine) in the treatment of major depressive episodes in adults. This too was also recently given the green light across the Atlantic and will be co-promoted in Europe with Takeda.
The CHMP has also issued a positive opinion on Hospira’s generic of UCB’s anti-epileptic Keppra (levetiracetam) and recommended switching the marketing authorisation for Laboratoires Biocodex’ Diacomit (stiripentol) from a conditional to a full approval. The latter is used for severe myoclonic epilepsy in infancy (SMEI), a very rare disease also known as Dravet’s syndrome.
Among other highlights, the CHMP also recommended expanding the label on UCB’s Cimzia (certolizumab pegol) to include psoriatic arthritis. It is already approved for rheumatoid arthritis, Crohn’s disease and axial spondyloarthritis.
Reacts to Novo insulin product recalls
Meantime, the EMA said it is “monitoring the situation closely” after Novo Nordisk said it is recalling certain batches of its prefilled insulin product Novoix 30 FlexPen and Penfill due to a manufacturing problem whereby some cartridges contained too many or too few insulin units per millilitre.
The EMA told patients to continue their treatment and to measure their blood glucose levels frequently int they have consulted their doctor. The agency added that it will ensure “appropriate measures are being taken by the company, including immediate corrective actions as well as permanent technical solutions to prevent reoccurrence”.
