The European Medicines Agency (EMA)’s human medicines committee (CHMP) has recommended five new medicines for approval at its December 2019 meeting, bringing the total tally for the year to 66 recommendations.
First up, the committee suggested granting a marketing authorisation for Novartis’ neovascular wet age-related macular degeneration drug, Beovu (brolucizumab). The monoclonal antibody is indicated to treat the disease, which affects the central part of the retina at the back of the eye and causes loss of “straight-ahead” vision.
The positive opinion bring the company “another step closer to providing wet AMD patients in Europe with a new treatment option” explained Nikos Tripodis, worldwide franchise head, Novartis Ophthalmology.
He continued to say, “At Novartis, we remain committed to reimagining treatments for patients suffering from wet AMD, a leading cause of blindness worldwide.”
Further, a positive opinion was adopted for Recarbrio (imipenem/cilastatin/relebactam), MSD’s medicine for infections due to aerobic Gram-negative organisms in adults with limited treatment options.
Pfizer’s biosimilar Amsparity (adalimumab) also got a nod for the treatment of certain inflammatory and autoimmune disorders, marking itself as a rival to the world’s best selling drug; Abbvie’s Humira.
Finally, the group recommended granting marketing authorisations for two generic medicines from Accord: Azacitidine Accord (azacitidine), for the treatment of myelodysplastic syndromes, chronic myelomonocytic leukaemia and acute myeloid leukaemia, and Dexmedetomidine Accord (dexmedetomidine), for the induction of light to moderate sedation of adults in an intensive care unit.
In addition to the novel medicines, the CHMP suggested extensions for multiple existing treatments, including Helsinn Birex’s Akynzeo (fosnetupitant / palonosetron), Janssen’s multiple myeloma drug Darzalex (daratumumab) and Stelara (ustekinumab), also from Janssen.