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Ema

All articles tagged with #ema

health15 days ago•7 min saved

EU CHMP flags five medicines for approval and 13 indication extensions at March 2026 meeting

At its March 2026 meeting, the EMA CHMP recommended five medicines for approval (Adstiladrin, Imdylltra, Joenja, Zepzelca, Bopediat), plus extensions of indication for 13 other medicines. It upheld its previous decision to refuse a change to Hetlioz’s marketing authorisation and noted withdrawal of Blarcamesine Anavex. In the Tecovirimat SIGA case, the committee concluded it should no longer be used for mpox. Other updates include a new subcutaneous route for Sarclisa and a biosimilar development reflection paper. The agenda and minutes will be published by EMA in coming weeks.

via European Medicines Agency|

#biosimilars #chmp #ema

health1 month ago•3 min saved

EU poised to approve first single-shot COVID-19 and flu vaccine for 50+

The European Medicines Agency recommended EU-wide marketing authorisation for mCombriax, the first combined mRNA vaccine protecting people aged 50 and older against both COVID-19 and seasonal influenza in a single shot. In trials, antibodies against both viruses were non-inferior to existing vaccines, and the vaccine showed common short-term side effects (injection-site pain, fatigue, muscle/joint pain, fever, etc.). The European Commission will decide on authorization, after which price and reimbursement are set by individual member states.

via European Medicines Agency|

#covid-19 #ema #eu

business2 months ago•4 min saved

Amgen keeps Tavneos on market as regulators review trial data and safety

Amgen says it will not voluntarily withdraw Tavneos after an FDA request and will continue talks with regulators, even as the EMA re-examines Tavneos data integrity. The FDA is reviewing the original ChemoCentryx trial data and the drug’s risk-benefit profile due to rare hepatotoxicity, while Amgen asserts the underlying data are sound. Tavneos, approved in 2021 in the US and 2022 in the EU, remains a small but growing part of Amgen’s portfolio as it pursues milestones for other drugs like Uplizna and guides 2026 revenue higher after a 2025 showing of about $36.7B.

via Fierce Pharma|

#amgen #business #data-integrity

health5 months ago•3 min saved

CHMP Approves New Therapies for Immune Thrombocytopenia and Other Conditions

The EMA's CHMP recommended approval for two new medicines, Brinsupri for bronchiectasis and Wayrilz for immune thrombocytopenia, while advising against Rezurock for graft-versus-host disease. It also approved extensions for eight existing medicines, withdrew an application for hydrocortisone in preterm infants, confirmed the suspension of Oxbryta for sickle cell disease, and introduced a new administration route for Saphnelo. The meeting's agenda and minutes are forthcoming.

via European Medicines Agency|

#brinsupri #ema #health

health8 months ago•9 min saved

European Regulators Show Mixed Support for Lilly’s Alzheimer’s Treatments

The EMA's CHMP recommended approval for 13 new medicines in July 2025, including treatments for rare diseases, cancer, HIV prevention, and postpartum depression, along with biosimilars, generics, and updates on vaccine compositions. Several applications were withdrawn or received negative opinions, while some medicines underwent re-examination or extension of indications. The meeting also included safety reviews and updates on ongoing public health procedures.

via European Medicines Agency|

#2025 #chmp #ema

health1 year ago•4 min saved

Leqembi Endorsed for Early Alzheimer's Therapy

The European Medicines Agency's human medicines committee has recommended Leqembi (lecanemab) for treating early Alzheimer's disease in patients with one or no copies of the ApoE4 gene, due to a lower risk of amyloid-related imaging abnormalities (ARIA). This decision follows a re-examination of data showing Leqembi's benefits in slowing cognitive decline outweigh its risks in this restricted population. The recommendation includes safety measures like MRI monitoring and a controlled access programme to mitigate ARIA risks. The decision now awaits approval from the European Commission.

via European Medicines Agency ||

#alzheimers #apoe4 #aria

health1 year ago•7 min saved

"Key Takeaways from CHMP Meeting, May 2024"

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended 14 new medicines for approval and seven for extended therapeutic indications during its May 2024 meeting. Highlights include Adzynma for congenital thrombotic thrombocytopenic purpura, Akantior for acanthamoeba keratitis, and Ixchiq, the first EU vaccine for Chikungunya. Additionally, the CHMP confirmed the refusal of marketing authorisation for Nezglyal and restarted the evaluation for Translarna's renewal.

via European Medicines Agency ||

#approvals #chmp #ema

medicine2 years ago•3 min saved

"Key Takeaways from CHMP Meeting: January 2024"

The Committee for Medicinal Products for Human Use (CHMP) recommended three new medicines for approval, including Exblifep for urinary tract infections, Ryzneuta for neutropenia, and Niapelf for schizophrenia, while refusing marketing authorizations for Nezglyal and Syfovre. The committee also recommended extensions of therapeutic indication for four medicines and confirmed its original recommendation to not renew the conditional marketing authorization for Translarna. Additionally, the CHMP endorsed measures to minimize risks for medicines containing pseudoephedrine and will re-examine its opinion on generic medicines following a request.

via European Medicines Agency ||

#approval #chmp #ema

health2 years ago•1 min saved

"EMA Issues Warning on Omega-3-Acid Ethyl Esters Link to AF"

The European Medicines Agency (EMA) has confirmed that atrial fibrillation (AF) will now be listed as a common side effect of medicinal products containing omega-3-acid ethyl esters. The EMA's safety committee found a dose-dependent increase in the risk of AF in patients with cardiovascular diseases or risk factors who were treated with omega-3-acid ethyl esters. The highest risk was observed at a dose of 4 g/d. Physicians, pharmacists, and patients will be informed of this risk through an update to the product characteristics and a notification to healthcare professionals.

via Medscape|

#atrial-fibrillation #cardiovascular-diseases #ema

health2 years ago•2 min saved

"EMA Expands Investigation into GLP-1 Receptor Agonists and Suicidal Thoughts"

The European Medicines Agency (EMA) is conducting a review of GLP-1 receptor agonists, including Ozempic, Saxenda, and Wegovy, due to reports of suicidal thoughts and self-injury. The review was triggered by the Icelandic medicines agency and is analyzing approximately 150 cases. It is unclear whether these cases are directly linked to the medications or other factors. The review is expected to conclude in November 2023. Patients and healthcare professionals are advised to use these medications according to approved guidelines and report any suspected side effects.

via European Medicines Agency ||

#ema #glp-1-receptor-agonists #health

healthcare3 years ago•3 min saved

European Approval of ALS Drug AMX0035 Faces Review Hurdle

Amylyx Pharmaceuticals faces a second round of questions from the Committee for Medicinal Products for Human Use (CHMP) in its bid to have AMX0035 approved as a treatment for amyotrophic lateral sclerosis (ALS) in Europe. The company will respond to the questions and expects an opinion from the committee by mid-2023. The EMA will consider that opinion in its decision on AMX0035’s potential approval.

via ALS News Today|

#als #amx0035 #amylyx-pharmaceuticals