EMA Recommends Eight Medicines for Approval in April

At its April 2024 meeting, the European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended eight medicines for approval: Altuvoct, Fruzaqla, Jeraygo, Obgemsa, Truqap, Tofidence, Wezenla, and Eribulin Baxter (1).

Altuvoct (efanescotocog alfa) was recommended for a marketing authorization for the treatment and prophylaxis of bleeding in patients with hemophilia A, which is a rare genetic bleeding disorder cause by a lack of factor VIII. Fruzaqla (fruquintinib) received a positive opinion for the treatment of patients with previously treated metastatic colorectal cancer. Jeraygo (aprocitentan) also received a positive opinion, for the treatment of resistant hypertension. CHMP gave a positive opinion to Obgemsa (vibegron) for the treatment of adult patients with overactive bladder syndrome. Truqap (capivasertib) received a positive opinion for the treatment of locally advanced or metastatic breast cancer with one or more specific mutations.

Tofidence (tocilizumab) and Wezenla (ustekinumab), both biosimilar medicines, received positive opinions from the committee. Tofidence received a positive opinion for the treatment of COVID-19, rheumatoid arthritis, systemic juvenile idiopathic arthritis, and pediatric plaque psoriasis. Wenzela received its positive opinion for the treatment of plaque psoriasis, including pediatric plaque psoriasis, psoriatic arthritis, and Crohn’s disease. Erubulin Baxter (eribulin), a generic medicine intended to treat breast cancer and liposarcoma, a rare disease which develops in fatty tissue, also received a positive opinion from the CHMP.

In addition to the positive opinions, two applications for marketing authorization were withdrawn. The first was for GeGant, a radionuclide generator that doctors can use to label diagnostic medicines. A question-and-answer document on the withdrawal of GeGrant is available on the EMA website. The second was Upstelda, a biosimilar treatment for plaque psoriasis, psoriatic arthritis, and Crohn’s disease, which is a duplicate of Wezenla. The committee also recommended extensions of indication for six medicines already authorized in the European Union: Alescensa, Opdivo, Rozlytrek, Rybrevant, Sirturo, and Triumeq. The committee recommended new contraindications on the co-administration of Reyataz (Atazanavir) with ivosidenib and encorafenib, and with phenobarbital, phenytoin, and carbamazepine.

In regulatory updates, EMA is currently reviewing the impact of the appellate judgement of the Court of Justice (March 14, 2024) on the evaluation of Hopveus, the subject of the court case, as well as other regulatory procedures. Because of this, CHMP has created a new ad-hoc expert group (AHEG) for Syfovre and will reset the evaluation procedure for this treatment from the point of reset to day 180 of the initial assessment. The judgement reviewed questions related to the organization of EMA’s Scientific Advisory Groups and AHEGs, which are both groups that are called upon by EMA to respond to questions from the EMA’s committees during a medicine evaluation. The agency wrote that it is “considering the impact of the appellate judgment on the evaluation of other regulatory procedures,” and “will further communicate as appropriate” (1).

Reference:

1. EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024. Press release, Apr. 26, 2024.