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BioWorld - Thursday, August 11, 2022
Home » Topics » Regulatory » CHMP

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Amvuttra

Alnylam’s Amvuttra rare disease drug among positive recommendations from Europe’s CHMP

July 22, 2022
By Richard Staines
No Comments
Alnylam Pharmaceuticals Inc.’s Amvuttra (vutrisiran), a treatment for the rare disease hereditary transthyretin-mediated amyloidosis, was among medicines recommended for approval by regulators from Europe’s Committee for Medicinal Products for Human Use (CHMP) in a busy sitting.
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Rare disease illustration

Rare disease therapies from Sanofi, Eiger and PTC backed by Europe’s CHMP

May 20, 2022
By Richard Staines
No Comments
The first therapies for several rare diseases were among medicines given the green light by European regulators at their monthly meeting. The EMA’s Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion for Sanofi SA’s Xenpozyme (olipudase alfa) for two types of Niemann-Pick disease and Eiger Biopharmaceuticals Inc.’s Zokinvy (lonafarnib) for children with Hutchinson-Gilford progeria syndrome or progeroid laminopathies. PTC Therapeutics Inc.’s Upstaza (eladocagene exuparvovec), the first medicine for adults and children with aromatic L-amino decarboxylase deficiency, was also backed by the CHMP.
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Aduhelm product image

Biogen withdraws EU Aduhelm filing amid announcement of latest CHMP opinions

April 22, 2022
By Richard Staines
No Comments
Biogen Inc. has given up on its attempt to get its Alzheimer’s disease drug Aduhelm (aducanumab) approved by regulators in Europe, deciding to withdraw its filing midway through a review of a previous rejection. The company had asked the European Medicines Agency’s CHMP to reconsider its negative opinion for Aduhelm in December 2021. But its subsidiary in the Netherlands wrote to the EMA this week saying that it had decided to withdraw its marketing authorization application after all.
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EU flag, syringe, capsules

Janssen/Legend’s Carvykti headed for approval in Europe after nod from regulators

March 29, 2022
By Richard Staines
No Comments
Janssen Pharmaceutical Cos, Inc.’s CAR T-cell therapy, Carvykti (ciltacabtagene autoleucel), looks set for approval in Europe after endorsement by regulators for advanced multiple myeloma. At its monthly meeting, the EMA’s Committee for Medicinal Products for Human Use recommended Carvykti for adults with relapsed and refractory disease who have received at least three prior therapies and whose cancer has worsened since their last treatment.
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EU flag, syringe, capsules

Janssen/Legend’s Carvykti headed for approval in Europe after nod from regulators

March 25, 2022
By Richard Staines
No Comments
Janssen Pharmaceutical Cos, Inc.’s CAR T-cell therapy, Carvykti (ciltacabtagene autoleucel), looks set for approval in Europe after endorsement by regulators for advanced multiple myeloma. At its monthly meeting, the EMA’s Committee for Medicinal Products for Human Use recommended Carvykti for adults with relapsed and refractory disease who have received at least three prior therapies and whose cancer has worsened since their last treatment.
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Orphazyme’s rare disease drug set for rejection after European regulators’ meeting

Feb. 25, 2022
By Richard Staines
No Comments
After a rejection by the FDA in June, it looks like Orphazyme A/S is headed for disappointment in Europe too with arimoclomol for Niemann-Pick disease type C, a rare and potentially fatal inherited condition in which fat builds in tissues and organs. The Copenhagen-based company said it was summoned before experts to give an “oral explanation” about the drug, something that only occurs if the European Medicines Agency’s CHMP has developed major doubts during its review.
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Blueprint’s Ayvakyt among drugs heading for label extensions in Europe

Jan. 31, 2022
By Richard Staines
No Comments

Blueprint Medicines Corp.’s cancer drug Ayvakyt (avapritinib) looks set to gain an expanded label in Europe, amid a flurry of decisions from the European Medicines Agency’s CHMP scientific committee. Late last week the CHMP gave a positive opinion for Ayvakyt for treatment of adults with advanced systemic mastocytosis, meaning the drug is likely to gain a further European indication in the coming weeks.


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EMA icons

EMA’s CHMP rejects Biogen’s application for European approval of Aduhelm in Alzheimer’s

Dec. 17, 2021
By Cormac Sheridan
No Comments
DUBLIN – The EMA has rejected Biogen Inc.’s application for European Union approval of Aduhelm (aducanumab), its controversial Alzheimer’s disease drug. Its human medicines committee (CHMP) issued a negative opinion on Biogen’s dossier during its December meeting this week, stating that the data from the key studies submitted in support of the application “were conflicting and did not show overall that Aduhelm was effective at treating adults with early stage Alzheimer’s disease.”
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Biogen logo

Biogen knocked by ‘negative trend vote’ for Alzheimer’s drug in Europe

Nov. 17, 2021
By Jennifer Boggs
No Comments
A European approval for Alzheimer’s drug aducanumab by year-end looks even more in doubt. A week after being called in before the EMA’s Committee for Medicinal Products for Human Use (CHMP) for an oral explanation of the trial data, Biogen Inc. said it received a “negative trend vote” on the marketing authorization application. A formal opinion by the CHMP is expected at its December meeting, but analysts are not optimistic.
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Aduhelm product image

European regulators put off decision on Biogen’s controversial Alzheimer’s drug

Nov. 12, 2021
By Richard Staines
No Comments
European regulators have put off a decision on Biogen Inc and Eisai, Co. Ltd.’s controversial Alzheimer’s drug, aducanumab, for likely another month, after the companies announced further supportive data from a follow-up under review by the FDA.
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