CHMP recommends eight new medicines, including first CAR-T for multiple myeloma

Regulatory NewsRegulatory News | 25 June 2021 |  By 

At its June meeting, the European Medicine Agency’s (EMA) human medicines committee recommended eight new medicines for approval, including Europe’s first chimeric antigen receptor T-cell therapy for multiple myeloma, two orphan drugs, three non-orphan medicines and two generic drugs.
The Committee for Medicinal Products for Human Use (CHMP) also issued one negative opinion and recommended extending the therapeutic indications of six other medicines.
The committee recommended conditional marketing authorization for Celgene’s Abecma (idecabtagene vicleucel) a cell-based gene therapy for treating adult patients with relapsed and refractory multiple myeloma who have received at least three previous therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and whose cancer has worsened since receiving the last treatment. The US Food and Drug Administration licensed Abecma for a similar indication last March. (RELATED:  FDA Approvals Roundup: Abecma, Vyxeos, Myrbetriq, Regulatory Focus 31 March 2021)
EMA said that each dose of Abecma “is created by collecting a patient’s own T-cells (i.e. white blood cells that help the body fight infection) and genetically modifying them so that they include a new gene that helps the body target and kill the myeloma cells. These modified immune cells are then infused back into the patient’s blood.”
Of the orphan drugs, BioMarin’s Voxzogo (vosoritide) received a positive opinion to treat achondroplasia, a condition that impairs bone growth and causes dwarfism in patients 2 years of age and above whose epiphyses are not closed.
The other orphan drug recommended for approval was Samsung Bioepis’ Byooviz (ranibizumab), a biosimilar version of Novartis’ Lucentis, to treat neovascular (wet) age-related macular degeneration and visual impairment due to diabetes.
Samsung Bioepis applauded the CHMP decision. “We are very proud to see Byooviz becoming the first biosimilar of ranibizumab to be recommended for approval in Europe. This marks an important milestone for our company, as this is one step forward to expanding patient access to treatments for retinal vascular disorders,” said Kyung-Ah Kim, the company’s senior vice president and head of development.
Incyte Biosciences and MorphoSys’ Minjuvi (tafasitamab) was given conditional marketing authorization to treat relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in adults who are not eligible for autologous stem-cell transplant (ASCT).
UCB Pharma’s Bimzelx (bimekizumab) received a positive opinion to treat moderate to severe plaque psoriasis.
Lastly, Astellas Pharma Europe’s Evrenzo (roxadustat) received a positive recommendation for its anemia treatment for patients with chronic kidney disease.
The two generics recommended for approval are Mylan’s generic versions of Janssen-Cilag’s Zytiga (abiraterone acetate) to treat metastatic prostate cancer and Novartis’ Gilenya (fingolimod) to treat relapsing-remitting multiple sclerosis.
One company, Cancer Prevention Pharma of Ireland’s Flynpovi (eflornithine/sulindac) received a negative opinion for its medicine to treat adults with familial adenomatous polyposis (FAP).
CHMP recommended extending the therapeutic indications for six medicines: AstraZeneca’s Edistride (dapagliflozin), AstraZeneca’s Forxiga (dapagliflozin), Amicus Therapeutics' Galafold (migalastat), Bristol-Myers Squibb’s Opdivo (nivolumab), AbbVie Deutschland GmbH’s Rinvoq (upadacitinib) and Pfizer Europe’s Xeljanz (tofacitinib).
The committee also began an Article 31 review of the efficacy and safety of the anti-anxiety medicine Stresam (etifoxine) at the request of French regulators. According to EMA, a recent study and an analysis of available safety data for the drug raises questions about its efficacy and the ongoing occurrence of rare but serious side effects. Stresam is authorized in France, Malta, Bulgaria and Romania.
CHMP meeting highlights


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