Tuesday, October 12 2021

Posted on June 25, 2021 | Through Joanne S. Eglovich

At its June meeting, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use recommended the approval of eight new medicines, including the first European T-cell treatment with chimeric antigen receptor for the multiple myeloma, two orphan drugs, three non-orphan drugs and two generic drugs.

The Committee for Medicinal Products for Human Use (CHMP) also issued a negative opinion and recommended the extension of the therapeutic indications for six other medicinal products.

The committee recommended conditional marketing authorization for Celgene’s Abecma (idecabtagene vicleucel), a cellular gene therapy for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three previous treatments, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38, and whose cancer has worsened since the last treatment. The United States Food and Drug Administration cleared Abecma for a similar indication last March. (RELATED: Summary of FDA Approvals: Abecma, Vyxeos, Myrbetriq, Regulatory guidance March 31, 2021)

The EMA said that each dose of Abecma “is created by collecting a patient’s own T cells (that is, white blood cells that help the body fight infection) and genetically altering them. so that they include a new gene that helps the body target and kill myeloma cells, and these modified immune cells are then injected back into the patient’s blood.

Among orphan drugs, Voxzogo (vosoritide) by BioMarin has received positive reviews for treating achondroplasia, a condition that impairs bone growth and causes dwarfism in patients 2 years of age and older whose epiphyses are not closed.

The other orphan drug recommended for approval was Byooviz (ranibizumab) from Samsung Bioepis, a biosimilar version of Lucentis from Novartis, to treat age-related neovascular (wet) macular degeneration and visual impairment due to diabetes.

Samsung Bioepis applauded the CHMP’s decision. “We are very proud to see Byooviz become the first ranibizumab biosimilar to be recommended for approval in Europe. This marks an important milestone for our company, as it is a step forward in expanding patient access to treatment for retinal vascular disorders, ”said Kyung-Ah Kim, senior vice president and responsible for the development of the company.

Minjuvi (tafasitamab) from Incyte Biosciences and MorphoSys has received conditional marketing authorization to treat relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in adults ineligible for autologous stem cell transplantation (ASCT) .

Bimzelx (bimekizumab) from UCB Pharma has received a favorable opinion for the treatment of moderate to severe plaque psoriasis.

Finally, Evrenzo (roxadustat) from Astellas Pharma Europe received a positive recommendation for its treatment of anemia in patients with chronic kidney disease.

The two generics recommended for approval are the generic versions of Mylan of Zytiga by Janssen-Cilag (abiraterone acetate) for treating metastatic prostate cancer and Gilenya by Novartis (fingolimod) for treating relapsing-remitting multiple sclerosis.

A 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).

The CHMP recommended extending the therapeutic indications of six medicines: Edistride from AstraZeneca (dapagliflozin), Forxiga from AstraZeneca (dapagliflozin), Galafold from Amicus Therapeutics (migalastat), Opdivo (nivolumab) from Bristol-Myers Squibb, Rinvoq AbbVie Deutschland (tofacitinib).

The committee also initiated a section 31 review of the efficacy and safety of the anti-anxiety drug Stresam (etifoxine) at the request of French regulators. According to the EMA, a recent study and analysis of the safety data available for the drug raises questions about its effectiveness and the continued occurrence of rare but serious side effects. Stresam is authorized in France, Malta, Bulgaria and Romania.

Highlights of the CHMP meeting

© 2021 Society of Regulatory Affairs Professionals.

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