Positive Opinion

Novartis’ Leqvio (inclisiran) Receives CHMP’s Positive Opinion for Approval to Treat Hypercholesterolemia

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Shots: The CHMP’s positive opinion is based on ORION program including P-III studies assessing Leqvio in 3,600+ patients on a maximally tolerated statin dose. Inclisiran demonstrated effective and sustained LDL-C reduction of up to 52% with 2doses/yr, after an initial dose and one @3mos., in… Read More »Novartis’ Leqvio (inclisiran) Receives CHMP’s Positive Opinion for Approval to Treat Hypercholesterolemia

Centus Biotherapeutics’ Equidacent (bevacizumab, biosimilar) Receives CHMP’s Positive Opinion for the Treatment of Multiple Cancer Indications

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Shots: The EMA’s CHMP has adopted a positive opinion recommending the MAA of Centus’ Equidacent (bevacizumab), a biosimilar to Roche’s Avastin to treat carcinoma of the colon or rectum, breast cancer, NSCLC, RCC, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the… Read More »Centus Biotherapeutics’ Equidacent (bevacizumab, biosimilar) Receives CHMP’s Positive Opinion for the Treatment of Multiple Cancer Indications

Gilead and Galapagos’ Jyseleca (filgotinib) Receive the CHMP’s Positive Opinion for Moderate to Severe Rheumatoid Arthritis

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Shots: Then CHMP’s positive opinion is based on P-III FINCH and P-II DARWIN programs that included 4,544 RA patient-years of experience with filgotinib. All three FINCH trials involve a broad range of patients that met their 1EPs  In the trials, the drug achieved ACR20/50/70 and… Read More »Gilead and Galapagos’ Jyseleca (filgotinib) Receive the CHMP’s Positive Opinion for Moderate to Severe Rheumatoid Arthritis