European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) 10 drugs recommended for approval: Four of them are orphan drugs, one is a biosimilar and two are generic drugs.This time, it includes two vaccines and a treatment First or cancer.
Furthermore, he agreed Expansion of indications for six authorized drugs Previously in the EU.
First, regarding new drugs, there are two vaccines against avian influenza, or bird flu, both from Segirus. Cell epidemicintended for use in immunization during this animal-origin influenza outbreak, while incelipan It will only appear when a pandemic is officially declared.
For orphan medicinal products, CHMP recommends the grant of conditional marketing authorization philsparry (sparsentan), from Vifor, for the treatment of primary immunoglobulin A nephropathy. Quarsodi (tofersen), from Biogen, marketing authorization is for “exceptional circumstances.” This is a new treatment for adults with amyotrophic lateral sclerosis (First). According to details from the European agency, the drug is suitable for patients with mutations in the superoxide dismutase 1 (SOD1) gene.
The other half of the orphan list consists of znez (retifanlimab) from Incyte Biosciences for the treatment of Merkel cell carcinoma and voidya (danicopan), the first oral treatment for residual hemolytic anemia in patients with paroxysmal nocturnal hemoglobinuria. The Alexion drug is supported through the EMA’s Priority Medicines (Prime) programme.
The approval also grants marketing authorization for a biosimilar from Samsung Bioepis called pizchiva (ustekinumab) is used to treat plaque psoriasis, including pediatric plaque psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn’s disease.
On the other hand, there are two generic drugs that received positive reviews from the committee, both from Accord Healthcare: apremilast protocol (apremilast), used to treat psoriatic arthritis, psoriasis and Behcet’s disease; and nintedanib protocol (nintedanib) for use in adults with idiopathic pulmonary fibrosis, other chronic fibrosing interstitial lung diseases with a progressive phenotype, and interstitial lung diseases associated with systemic sclerosis.
Finally, there is Tizweni (tislelizumab) from BeiGene. The drug is indicated for adults with locally advanced or metastatic non-small cell lung cancer.
Recommended extensions and other questions
In addition to new medicines, the EMA Committee also approved indication extensions for medicines previously authorized in the EU: Cibinqo, Kalydeco, Keytruda, Xromi, Carvykti and Reblozyl. The last two were orphans.
The agency’s communication also details orphan drug applicants Nezger and siffor Asking for a new review of the EMA’s opinion, the EMA detailed that once it receives the reasons for the request, the agency will re-examine its opinion and issue a final recommendation.
Finally, detailing what CHMP has done to Ibuprofen NVT “There are disagreements between EU member states regarding authorization.” “The Commission considered that the bioequivalence of ibuprofen NVT 400 mg to its reference medicine has not been demonstrated and concluded that the benefits of the medicine did not outweigh its risks. In Lithuania The marketing authorization granted cannot be recognized in Spain, where the company requested marketing authorization. Furthermore, the marketing authorization in Lithuania and the other Member States that have authorized the medicine (Estonia, France, Latvia, Poland and Romania) should be suspended,” EMA details introduced.
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