he Committee for Medicinal Products for Human Use The European Medicines Agency (EMA)’s CHMP (CHMP) ended September 2023 with Recommended approval of nine new drugs.These include the treatment of atomistic dermatitis, glioma and other diseases leukemiahypoparathyroidism, myasthenia gravis, breast cancer or heart failure.
During the meeting, CHMP also made recommendations Expand treatment indications The European Union has approved 11 drugs, which may increase treatment options for various medical conditions.In addition, he recommended Eleven drugs not renewedand withdrew three applications.
Nine drugs recommended for approval
CHMP recommends approval for marketing Ebuglis Indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents with positive opinions Finlay For the treatment of glioma, a type of brain tumor that originates in glial cells.
Also included in its recommendations Van Fleeta (quizartinib), a drug used to treat adult patients with acute myeloid leukemia jovipas (palopegteriparatide), a parathyroid hormone replacement therapy used to treat chronic hypoparathyroidism in adults.
Zbriske (zilucoplan) receives positive review for treatment of generalized myasthenia gravis, an autoimmune neuromuscular disease, in adults Hevenda (trastuzumab) is a biosimilar recommended for the treatment of early-stage and metastatic breast cancer and metastatic gastric cancer.
There are also recommendations for zoonotic influenza vaccines Sekiruswill be used for active immunization against the H5N1 subtype of influenza A virus.
Akmeldi (enalapril maleate), has been recommended for pediatric treatment of heart failure and Catiolanze (latanoprost) reduces elevated intraocular pressure.
The committee also recommended expand Uniform indicationEleven drugs Authorized in the EU. They are: Adcetris, Enhertu, Kaftrio, Kalydeco, Keytruda, Nordimet, Olumiant, Pepaxti, Ryeqo, Takhzyro and Voxzogo.
Not renewing authorization and withdrawing application
In addition, CHMP recommends Marketing authorization not updated Conditions for both drugs:translanafor the treatment of Duchenne muscular dystrophy, and Bren Representative (belantamab mafodotin), used to treat multiple myeloma.
All these CHMP recommendations will be submitted to the European Commission (EC) for review and final decision, which will be legally binding on all EU member states.
Additionally, during your evaluation Three applications were withdrawn Marketing Authorization.Get the medicine Lutorazfor use in cancer patients to reduce the duration of neutropenia and prevent febrile neutropenia; to the drug Vivreaufor the treatment and prevention of vulvovaginal candidiasis because Sky Kewenused to prevent the elderly from being infected with the new coronavirus.
Although it may contain statements, data, or notes from health agencies or professionals, the information contained in medical writing is compiled and prepared by journalists. Readers are advised to consult a healthcare professional with any health-related questions.