CHMP recently recommended the approval of 7 new drugs
PharmaTimes reported on December 17 that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended the approval of seven drugs. The committee supports the approval of two orphan drugs, Besremi (ropeginterferon alfa-2b) for OP Orphan's treatment of asymptomatic splenomegaly, and medec for Trecondi pre-treatment for allogeneic hematopoietic stem cell transplantation. (treosulfan).
Lusutrombopag Shionogi (lusutrombopag) of Yanyeyi Pharmaceutical is supported for severe thrombocytopenia and is suitable for adult patients with chronic liver disease undergoing interventional surgery. In addition, the company's Rizmoic (naldemedine) is supported for the treatment of opioid-induced constipation.
PARI Pharmaceutical's Tobramycin PARI (tobramycin), also a approved drug, is a mixed drug for chronic lung infections caused by Pseudomonas aeruginosa (the drug is based in part on a preclinical trial of a reference product) And the results of clinical trials, and to some extent new data), for patients with cystic fibrosis aged 6 years and older.
Pfizer's Avastin biosimilar Zirabev (bevacizumab) received positive advice on the treatment of colon, rectal, breast, non-small cell lung, kidney and cervical cancer, and the committee also recommended the approval of Dipharma's imitation. Pharmaceutical Miglustat Dipharma, a drug used to treat adult patients with moderate to severe type 1 Gaucher disease.
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