Has been available in Europe since 2019. In Germany, 45% of PNH patients on Soliris had switched to Ultomiris as of Oct 19 —around three months ahead of the time Ultomiris took to hit the same milestone in the US .
Available in UK. 100mg/ml conc for soln for inf in vial, 3ml=£4,533.00; 11ml=£16,621.00. Also 10mg/ml conc, 30ml= £4,533.00 .
Ravulizumab was withdrawn from the Community Register of designated orphan medicinal products on 11 June 2019 on request of the sponsor .
Alexion is awaiting a positive recommendation from NICE and agreed funding from NHS England before providing a price or launch date. They are working with the HTA body to ensure a timely appraisal .
Alexion announced that the European Commission has approved ravulizumab for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) as below ref 12 .
CHMP has adopted a positive opinion for ravulizumab for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) with haemolysis with clinical symptoms indicative of high disease activity and those treated with eculizumab for 6 months who are clinically stable .
A new market research report identifies ravulizumab as one of seven new drugs it believes will hit sales of $1 billion or more, the so-called “blockbuster” mark, by 2023 .
One month after launch of Ultomiris, Alexion announce 5% of US patients have switched from Soliris (eculizumab) and virtually 100% of new starts are with Ultomiris. The company aims for a 70% switch in 2 years and has similar ambitions for Europe, starting with Germany, where launch is anticipated mid 2019 .
FDA has approved ravulizumab (ULTOMIRIS™) for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) .
Filed in EU for treatment of patients with PNH. The application is supported by comprehensive data from two PIII trials in more than 440 patients (the largest population of patients with PNH ever studied in Phase 3), which included patients who had never received a complement inhibitor, and patients who were stable on Soliris® (eculizumab) and switched to ALXN1210 .
The company announched plans for regulatory submissions of ALXN1210 in PNH in the US., EU and Japan in the 2nd half of 2018 .
Will be filed in the EU via the centralised procedure .
ALXN 1210 gains orphan drug status for paroxysmal nocturnal haemoglobinuris in the US; orphan designation in the EU was granted in June 2016. A PIII trial in the US has recently started and a PII trial (NCT02605993, EudraCT2015-002674-20) is in progress in several countries including the UK .