The European Medicines Agency (EMA) plays a crucial role in the regulation of the pharmaceutical field in the European Union. Among the EMA’s responsibilities is the evaluation of medicines for which pharmaceutical companies apply for marketing authorizations at a centralized level in the EU. This assessment is important to ensure that medicines reaching the European market are safe, effective and of good quality.
Each month, the EMA’s Committee for Medicinal Products for Human Use (CHMP) meets to assess medicines and decide whether or not to recommend authorisation. The CHMP recommendation is a crucial step in the process of drug authorization in the European Union.
At the meeting in July, the CHMP experts recommended the approval of 14 medicines for placing on the EU market. These include a generic medicine, which is an equivalent variant of an already authorized medicine, and three biosimilars, which are biologically similar medicines to already authorized medicines.
The CHMP also recommended the extension of the therapeutic indication to seven other treatments, which means that these drugs will be able to be used for conditions other than those for which they were originally approved.
The marketing authorization decision belongs to the European Commission, which usually follows the recommendations of EMA experts.
Thus, during the CHMP meeting of July 17-20, the authorization of the following drugs was recommended:
Abrysvo (bivalent, recombinant), vaccine to protect young children and the elderly against respiratory syncytial virus (RSV) infection. It’s the first
Apretude (cabotegravir)for pre-exposure prophylaxis against HIV-1 infection.
Degarelix Accord (degarelix acetate)generic drug for the treatment of prostate cancer.
Enrylaze (crisantaspase)for the treatment of acute lymphoblastic leukemia.
Inakovi (Decitabine/Cedazuridine)for the treatment of acute myeloid leukemia.
Litfulo (ritlecitinib)for the treatment of severe alopecia areata.
Lyfnua (gefapixant)for the treatment of chronic refractory cough.
Orserdufor the treatment of breast cancer.
Talvey (talquetamab)for the treatment of multiple myeloma.
Tepkinly (epcoritamab)for the treatment of diffuse large B-cell lymphoma.
Tevimbra (tislelizumab)for the treatment of esophageal squamous carcinoma.
Tyenne (tocilizumab)biosimilar.
Tyruko (natalizumab), biosimilar.
Yesafili (aflibercept), biosimilar.
Source: 360medical.ro
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2023-07-24 20:12:49
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