Galapapositief schreef op 8 september 2020 09:51:Gilead’s Filgotinib also OK’d
The Second Committee also endorsed Gilead Sciences’ oral selective JAK1 inhibitor filgotinib for the treatment of rheumatoid arthritis (RA) inadequately controlled with existing treatments. All-case PMS will be required as a condition for approval.
The drug was submitted in Japan, the US, and Europe based on the results of a PIII program called FINCH. Regulators’ views on its approval differ between the US and EU. In July, the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) backed approval of the drug, and the final decision by the European Commission will be issued during the third quarter of 2020.
Meanwhile, the US FDA issued a complete response letter, rejecting its approval. The agency expressed concerns for the risks and benefits of the 200 mg tablet and requested Gilead submit additional data from two ongoing PII studies assessing “testicular toxicity,” and “semen test parameters.” At the Second Committee meeting, the Pharmaceuticals and Medical Devices Agency (PMDA) explained its views on the US regulator’s concerns, and the committee members concluded that there will be no problem with its approval.pj.jiho.jp/article/242804?searched_ke...Nu ook op de officiele website !!
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