CHMP recommends five new medicines, including gene therapy for multiple myeloma
The European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) last week recommended five new medicines for approval, including a gene therapy for multiple myeloma and an antibody therapy for preventing COVID-19, bringing the total number of treatments recommended for approval to 25 since the beginning of the year.The agency recommended approval of AstraZeneca’s monoclonal antibody Evusheld (tixagevimab/cilgavimab) for COVID-19 prevention. Evusheld is comprised of two monoclonal antibodies that when attached to the virus’ spike protein, block it from entering cells and causing an infection, according to a CHMP announcement.
In its review, CHMP evaluated data from over 5,000 patients, concluding the drug “reduced the risk of COVID-19 infection by 77%, with the duration of protection from the virus estimated to be at least six months.”
The drug also had “mild side effects with a small number of people reporting reactions at the injection site.” The committee concluded the medicine’s “benefits are greater than its risks.”
CHMP also issued a positive opinion for Janssen’s gene therapy Carvykti (ciltacabtagene autoleucel) for multiple myeloma. The treatment was supported through EMA’s PRIME scheme, which allows for early and enhanced dialogue with regulators for treatments that address unmet medical needs, said EMA. The therapy received a conditional marketing authorization.
Carvykti is a genetically modified autologous T cell immunotherapy targeting B-cell maturation antigen (BCMA). The drug’s benefits include a “high and durable response in patients with relapsed and refractory multiple myeloma,” said a CHMP announcement.
The committee also recommended the approval of two new hybrid applications submitted by Accord Healthcare: Camcevi (leuprorelin) for treating hormone-dependent prostate cancer and Zolsketil pegylated liposomal (doxorubicin) for treating breast cancer, ovarian cancer, progressive multiple myeloma and AIDS-related Kaposi’s sarcoma. Hybrid applications rely on the results of preclinical tests and clinical trials of an already authorized reference product as well as new data.
The committee recommended the approval of one generic medicine, SERB SA’s Amifampridine SERB (amifampridine), for treating Lambert-Eaton myasthenic syndrome.
In other actions, CHMP recommended extending the approved indications for five medicines: Ipsen’s Cabometyx (cabozantinib); Novartis’ Jakavi (ruxolitinib); Merck’s Keytruda (pembrolizumab), which was recommended for two new indications; Novartis’ Kymriah (tisagenlecleucel); and Roche’s Polivy (polatuzumab vedotin).
Sandoz withdrew its marketing authorization application for Dimherity (dimethyl fumarate) to treat relapsing multiple sclerosis, citing commercial reasons.
An incomplete data package derailed Jazz Pharmaceuticals’ application to expand the use of Vyxeous liposomal (daunorubicin/cytarabine) to treat young patients with acute myeloid leukemia (AML). The committee said that “relevant data from the study submitted with the application should be included in the medicine’s product information so that healthcare professionals have access to up-to-date data on the effects of Vyxeous liposomal in patients with relapsing or refractory AML.”
EMA
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