News briefing: A sweep of CHMP OKs for Alnylam, Kite, Novartis and others; Sanofi's big cancer play gets OK from UK watchdog
At this month’s meeting, the EMA’s Committee for Medicinal Products for Human Use issued recommendations of approval for 10 drugs. They include:
- Oxlumo (lumasiran), Alnylam’s RNAi candidate that snagged priority review from the FDA back in May. In June, the biotech released pivotal data which showed that 21 of 25 patients with PH1 (primary hyperoxaluria type 1), a rare liver condition, saw their oxalate levels fall to near the normal range after being treated with lumasiran, and just over half had numbers inside the normal range. That was compared to 0% in the placebo group, according to Alnylam.
- Kite’s Tecartus (KTE-X19), a CAR-T therapy approved by the FDA in July to treat adult patients with relapsed or refractory mantle cell lymphoma, a rare form of NHL. Ken Takeshita, head of global development at Gilead subsidiary Kite Therapeutics, boasted that the drug’s data were better than the company’s CAR-T drug Yescarta, which was approved in 2017. A company spokesperson said in July that the drug will be sold for $373,000.
- Novartis’ Leqvio (inclisiran), the LDL-C drug that was formerly a Medicines Company candidate. An August read-out from two Phase III trials showed consistency in efficacy and safety among patients with both hyperlipidemia and atherosclerotic cardiovascular disease despite statin therapy, according to the company. Around 88% of patients hit 50% reduction of LDL-C in at least one point during the 17-month study. After the 17-month mark, almost two-thirds of patients (66.4%) had a 50% reduction compared to 2.5% percent in the placebo group.
- Orchard Therapeutics’ Libmeldy for metachromatic leukodystrophy
- Janssen’s Rekambys for human immunodeficiency virus type 1 (HIV-1)
- ViiV Healthcare’s Vocabria for HIV-1
- Zogenix’s Fintepla for the treatment of seizures associated with Dravet syndrome
- Aimmune’s Palforzia for desensitising children and adolescents to peanut allergy
- AstraZeneca’s Trixeo Aerosphere for the maintenance treatment of chronic obstructive pulmonary disease
- Mylan’s lenalidomide for the treatment of multiple myeloma and follicular lymphoma
— Nicole DeFeudis
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