From their meeting in June, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. During the meeting the CHMP announced recommendations for three medicines for approval.
A marketing authorisation was recommended for Giapreza (angiotensin II) for the treatment of refractory hypotension in adults with septic or other distributive shock. A positive opinion was received from the CHMP for two informed consent applications. This included Azacitidine Celgene (azacitidine) for the treatment of myelodysplastic syndromes, chronic myelomonocytic leukaemia and acute myeloid leukemia; and Lacosamide UCB (lacosamide) for the treatment of partial-onset seizures with or without secondary generalisation.
A negative opinion recommending the refusal of a marketing authorisation was adopted by the CHMP for Evenity (romosozumab), which was expected to be used to treat osteoporosis.
The CHMP recommended extensions of indications for 12 medicines, including Victoza (liraglutide) to include the treatment of children and adolescents aged ten years or older with type 2 diabetes.
Following a review that concluded that there is no robust data demonstrating that bacterial lysate medicines are effective at treating existing respiratory infections or for preventing pneumonia, the CHMP have recommended that these medicines authorised for respiratory conditions should only be used for the prevention of recurrent respiratory infections, with the exception of pneumonia.
For the meeting summary, and a full list of approvals, opinions and withdrawals, please click here.