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Home » Topics » Regulatory » CHMP

CHMP
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Vyvgart Hytrulo

Argenx’s Vyvgart, Camurus’ Oczyesa among 16 recommended by CHMP

April 28, 2025
By Nuala Moran
Argenx NV is now well on the way to establishing a Vyvgart (efgartigimod alfa) franchise in severe autoimmune diseases, after getting the nod from the EMA in the treatment of progressive or relapsing chronic inflammatory demyelinating polyneuropathy.
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Leqembi gets another thumbs-up amid CHMP February recommendations

Feb. 28, 2025
By Nuala Moran
The EMA’s Committee for Medicinal products for Human Use (CHMP) is standing by its opinion on Leqembi (lecanemab) after the European .mission pushed back against a recommendation in November 2024 that the Alzheimer’s disease drug be approved
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EMA icons

Leqembi review stalls again at European regulator

Jan. 31, 2025
By Nuala Moran
EMA approval of the Alzheimer’s disease therapy Leqembi (lecanemab) has stalled once again, after the European Commission did not as usual nod through the agency’s recommendation, but told it to examine safety data that have recently become available.
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Welireg, Emcitate among drugs EMA recommends for approval

Dec. 13, 2024
By Nuala Moran
The EMA’s Committee for Medicinal Products for Human Use recommended 17 drugs for approval at its December meeting, bringing the total for 2024 to 114. That is up from the 77 drugs recommended for approval in 2023, of which 39 were novel.
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Eisai wins on appeal: CHMP recommends Leqembi for Alzheimer’s

Nov. 15, 2024
By Nuala Moran
The EMA has changed its mind about an earlier decision that the risks of Leqembi (lecanemab) outweigh the benefits and is now recommending the Alzheimer’s disease drug is approved for a subgroup of patients. That follows an appeal by Eisai Co. Ltd. and a re-examination of the data, after details relating to 274 patients with two copies of the ApoE4 gene were removed from the file.
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EU flag, syringe, capsules

CHMP nods for Korjuny, Alhemo; no, again, for Translarna, masitinib

Oct. 21, 2024
By Nuala Moran
The first bispecific antibody to win regulatory approval is about to make a comeback 10 years after being taken off the market in Europe for commercial reasons. Catumaxomab, then called Removab, and now reborn with the brand name Korjuny, received a positive opinion for the treatment of malignant ascites from the EMA’s Committee for Medicinal Products for Human Use (CHMP,) at its monthly meeting Oct. 14 to 17.
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EMA icons

EMA’s CHMP recommends Hympavzi for hemophilia, Elahere for cancer

Sep. 23, 2024
By Nuala Moran
For once, the EMA appears to have pipped the U.S. FDA to the post, with Pfizer Inc.’s hemophilia A and B therapy Hympavzi (marstacimab) recommended for approval in Europe on Sept. 20, while the U.S. PDUFA date is set for the fourth quarter of the year.
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European Union flag with wooden gavel

Advanz wins stay, keeps PBC drug Ocaliva on Europe market for now

Sep. 5, 2024
By Nuala Moran
Advanz Pharma Ltd. has won a stay on the withdrawal of its primary biliary cholangitis (PBC) drug, Ocaliva (obeticholic acid), after the European Commission (EC) said on Sept. 3 that the conditional marketing approval should be revoked. Following that, London-based Advanz launched a legal challenge, announcing on Sept 5 that the General Court of the EU has temporarily suspended the EC’s decision. As a result, the conditional marketing authorization for Ocaliva remains in place until further notice from the court, and the 7,000 existing patients – and new ones – will still have access to the farnesoid X receptor agonist.
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EU flags in front of the Berlaymont building

A CHMP thumbs up for Astellas’ Claudin18.2 zolbetuximab

July 30, 2024
By Tamra Sami
Astellas Pharma Inc.’s claudin (CLDN) 18.2-targeted monoclonal antibody, zolbetuximab, received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) and could be the first CLDN18.2 molecule to be approved in Europe if it receives final approval.
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Leqembi

EMA’s CHMP issues thumbs-down on Alzheimer’s drug Leqembi

July 30, 2024
By Nuala Moran
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of 14 drugs and the extension of the label of 11 others at its July meeting, but, inevitably, it was the decision to turn down the Alzheimer’s disease therapy Leqembi (lecanemab) that stirred the greatest reaction.
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