EMA recommends eight new medicines for approval
The European Medicines Agency’s Committee for Medicinal Products for Human recommends eight new medicines for approval, alongside 13 extensions of indication for existing medicines.
Among the headline recommendations at EMA’s Committee for Medicinal Products for Human Use (CHMP) meeting were three new treatments and one orphan medicine.
Lung fibrosis
Jascayd (nerandomilast), from Boehringer Ingelheim, for the treatment of idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) received a positive opinion IPF and PPF affects more than 500,000 people across the EU.
“Current treatments for IPF and PPF, including in patients whose PPF is associated with underlying autoimmune rheumatic diseases, have well‑known limitations. This is why advancing therapies with new mechanisms of action and better tolerability profiles is essential to improving how we manage these complex diseases,” said Professor Anna‑Maria Hoffmann‑Vold, Professor of Rheumatology at the University of Zurich and investigator in the FIBRONEER™ trial.
President of the European Pulmonary Fibrosis Federation (EU‑PFF), John K. Solheim, said that patients often faced unbearable side effects to the existing medicines, with many choosing to delay or stop taking them: “A treatment option for IPF and PPF that works and has fewer side‑effects offers real hope to families across Europe.”
HER2 cancers
Another significant approval recommendation was for Etcamah (camizestrant), developed by AstraZeneca. The medicine is intended for patients with advanced or metastatic HER2-negative breast cancer. The decision strengthens the growing field of precision oncology therapies tailored to specific tumour mutations.
“HER2-directed therapies have already transformed care for certain HER2-expressing cancers, including breast and gastric cancers. However, many other cancers overexpress HER2, and targeted treatment options remain unavailable for most of these tumour types,” said AstraZeneca, Executive Vice President, Oncology Susan Galbraith. “This positive opinion underscores the importance of precision oncology and marks an important step toward bringing a new targeted option to more patients in the EU living with HER2-positive solid tumours.”
Orphan treatment for PROS
Orphan medicine was Vijoice (alpelisib), developed by Novartis, which received a conditional marketing authorisation recommendation for severe PIK3CA-related overgrowth spectrum (PROS), a rare genetic condition causing uncontrolled tissue growth, malformations and tumours. EMA noted there are currently no authorised treatments for the disease, making this the first targeted therapy for patients with severe manifestations.
The committee also recommended extending therapeutic indications for several blockbuster medicines, including Keytruda (pembrolizumab), Merck’s widely used cancer immunotherapy has been the source of controversy following accusations by the International Consortium of Investigative Journalists (ICIJ) that the company was building a “fortress of patents”.
Other positive recommendations include AbbVie’s Boey (trenibotulinumtoxinE) - it is a similar approach to Botox, but is faster acting and shorter-term in effect. "We strongly believe Boey has the potential to offer a differentiated treatment option for many people who are still considering facial injectables," said Roopal Thakkar, Executive Vice President, Research and Development, Chief Scientific Officer, AbbVie.
For the full list of recommendations, click here.
Catherine Feore
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