Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors


European Commission approves Doptelet for treatment of severe thrombocytopenia – Dova Pharma

Written by | 10 Jul 2019 | All Medical News

Dova Pharmaceuticals, Inc announced that the European Commission (EC) has granted marketing authorization for Doptelet (avatrombopag) for the treatment of severe thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo an invasive procedure.

Safety and efficacy data from two global Phase III, double-blind, placebo-controlled trials, conducted in adults with thrombocytopenia (platelet count of less than 50,000/µL) and CLD, supported the EC marketing authorization. Doptelet was shown to be superior to placebo in increasing the proportion of patients not requiring platelet transfusions or rescue procedures for bleeding up to 7 days following a scheduled procedure in both trials and both the 40 mg and 60 mg treatment groups. Doptelet was also superior to placebo at the two secondary efficacy endpoints in each trial, i.e., the proportion of patients achieving a platelet count equal to or greater than 50,000/µL and the magnitude of the change in platelet counts from baseline to procedure day.

Newsletter Icon

Subscribe for our mailing list

If you're a healthcare professional you can sign up to our mailing list to receive high quality medical, pharmaceutical and healthcare E-Mails and E-Journals. Get the latest news and information across a broad range of specialities delivered straight to your inbox.


You can unsubscribe at any time using the 'Unsubscribe' link at the bottom of all our E-Mails, E-Journals and publications.