Since 2007, legislation known as the Advanced Therapy Medicinal Products Regulation (ATMP) has been in place to set regulatory standards for assessing gene, cell and tissue-engineered products. Yet in this time only four ATMPs have been approved for marketing.
The Committee for Medicinal Products for Human Use has given positive opinions to a new drug for depression developed by H. Lundbeck A/S, and one for pulmonary arterial hypertension (PAH) by Actelion Ltd. The decisions were announced on 25 October.
The European Medicines Agency’s main scientific committee has recommended that patients with chronic hepatitis C virus infection before or after a liver transplantation be given the opportunity to be treated with the experimental drug sofosbuvir.
An advisory panel of the US Food and Drug Administration has unanimously recommended approval of the Johnson & Johnson/Medivir AB treatment for patients infected with hepatitis C virus, simeprevir, in combination with interferon and ribavirin.
The US Food and Drug Administration has approved Opsumit (macitentan), a new drug for the treatment of pulmonary arterial hypertension. The developer is Switzerland-based Actelion Ltd.
The German reimbursement authority, the Federal Joint Committee (G-BA), has given a positive opinion to an ophthalmic product developed by ThromboGenics NV of Belgium for the treatment of vitreomacular traction, a condition that affects many older people.
The US Food and Drug Administration has agreed to give Alkermes Plc’s candidate drug for the adjunctive treatment of major depressive disorder a ‘fast track’ designation which means the company can have more frequent interactions with the regulator.
The US Food and Drug Administration has approved Brintellix (vortioxetine), an inhibitor of serotonin reuptake, for the treatment of major depressive disorder (MDD). The developers are H. Lundbeck A/S and Takeda Pharmaceutical Company Ltd.
The US Food and Drug Administration has expanded the indication for an artificial heart valve manufactured by Edwards Lifesciences Corp to include the treatment of patients who have inoperable aortic valve stenosis.
Roche’s antibody-drug conjugate for HER2-positive breast cancer, Kadcyla, has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), paving the way for marketing authorisation by the end of the year.