CHMP meeting highlights – March 2023
In the European Medicines Agency's March human medicines committee meeting, nine new medicines were recommended, including one for multiple sclerosis.
List view / Grid view
In the European Medicines Agency's March human medicines committee meeting, nine new medicines were recommended, including one for multiple sclerosis.
The first and only long-acting C5 inhibitor, Ultomiris (ravulizumab), has been permitted in Europe for adults with generalised myasthenia gravis.
The European Commission (EC) approved Ultomiris for children and adolescents with paroxysmal nocturnal haemoglobinuria (PNH).
The Committee for Medicinal Products for Human Use (CHMP) recommended two medicines for approval and provided a negative opinion on Nouryant.
In a Phase III study pegcetacoplan resulted in 86 percent of treatment-naïve paroxysmal nocturnal haemoglobinuria (PNH) patients achieving haemoglobin stabilisation.
NICE has recommended that Ultomiris (ravulizumab) be available on the NHS for patients with paroxysmal nocturnal haemoglobinuria and atypical haemolytic uraemic syndrome.
On the NICE’s recommendation, ravulizumab will be made available to hundreds of patients with paroxysmal nocturnal haemoglobinuria on the UK’s NHS.
Global mergers and acquisitions (M&A) activity last year was expected to decline from 2019 levels, mainly due to the COVID-19 pandemic and resulting uncertainty around the global economy, trade tensions between the US and China, and the presidential election in the US. However, James Baillieu from Bird & Bird reveals…