CHMP recommends eight new medicines in April, including two orphans

Regulatory NewsRegulatory News | 27 April 2021 |  By 

In its April meeting, the European Medicines Agency’s (EMA’s) human medicines committee recommended eight new medicines for approval, including three new non-orphan medicinal products and two orphan medicines.
EMA’s Committee for Medical Products for Human Use (CHMP) also issued positive opinions for extensions of therapeutic indications for nine medicines, bringing the total new indications for 2021 to 23.
Leo Pharma’s Adtralza (tralkinumab) was recommended by CHMP to treat moderate-to-severe atopic dermatitis.
Roche’s Enspryng (satralizumab) received a positive opinion to treat neuromyelitis optica spectrum disorders, while Koselugo (AstraZeneca, selumetinib) got the nod from CHMP to treat plexiform neurofibromas in pediatric patients with neurofibromatosis type 1. These two medicines received orphan designation from EMA during their development.
Regeneron’s Ireland Designated Activity Company received positive news for the PCSK9 inhibitor Evkeeza (evinacumab) to treat adults and teens with homozygous familial hypercholesterolemia.
The final April positive recommendation for a new medicine from CHMP went to Celgene Europe’s Onureg (azacytidine) for maintenance treatment of patients with acute myeloid leukemia.
CHMP gave positive recommendations for two generic medicines, KRKA’s version of abiraterone and Pinax Pharma’s Celsunax. Generic abiraterone was recommended to treat metastatic prostate cancer, while Celsunax (ioflupane I-23 radioisotope) was approved to detect loss of functional dopaminergic neuron terminals in the striatum of the brain.
Jayempi, Nova Laboratories’ azathioprine formulation, received a positive recommendation both as prophylaxis against transplant rejection and as an immunosuppressive antimetabolite. This recommendation for marketing authorization came after a hybrid application, which relied “in part on the results of pre-clinical tests and clinical trials of an already authorised reference product and in part on new data,” according to EMA.
Sanofi’s Aubagio (teriflunomide), Abbvie’s Maviret (glecaprevir/pibrentasvir) and Vencluxto (venetoclax), Bristol-Myers Squibb’s Nujolix (belatacept), Yervoy (ipilimumab) and Opdivo (nivolumab) were all recommended by CHMP for extensions of indication. AstraZeneca received a positive recommendation for an extension of indication for its Tagrisso (osimertinib).
Two of Teva’s budesonide/formoterol formulations, DuoResp Spiromax and BiResp Spiromax, also received recommendations for extensions of indication.
CHMP has yet to issue a negative opinion on a new medicine this year. The meeting summary issued by EMA has an accompanying annex indicating what types of scientific advice and protocol assistance have been given to date in 2021, including a summary of final scientific advice procedures stemming from the April meeting.


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