EC refuses to grant authorisation for Ipsen’s FOP treatment
20 Jul 2023
Orphan DrugDrug ApprovalPhase 3Breakthrough Therapy
Preview
Source: Pharmaceutical Technology
Ipsen’s palovarotene is intended to treat fibrodysplasia ossificans progressiva. Credit: Ipsen Pharma.
The European Commission (EC) has refused to grant marketing authorisation for Ipsen’s investigational therapy, palovarotene, intended to treat fibrodysplasia ossificans progressiva (FOP).
The EC’s decision comes after the Committee for Medicinal Products for Human Use (CHMP) provided a negative opinion in May 2023.
Recommended Reports
Preview
Source: Pharmaceutical Technology
ReportsNitric Oxide Synthase (NO Synthase or NOS or EC 1.14.13.39) Drugs in Development by Therapy Areas... GlobalData
Preview
Source: Pharmaceutical Technology
ReportsLOA and PTSR Model - Non-Disclosed GlobalData
View allCompanies IntelligenceIpsen SAC H M P INCView all
An oral therapy, palovarotene selectively acts on the retinoic-acid receptor gamma (RARγ).
It is the first-of-its-kind medicine to seek approval for FOP treatment.
Palovarotene has been analysed in a clinical programme, which included the Phase III MOVE clinical trial for FOP, for more than 15 years.
In the US, palovarotene obtained orphan drug and breakthrough therapy designations from the Food and Drug Administration to potentially treat FOP.
A decision on the approval by the US FDA is anticipated on 16 August 2023.
The company also noted that regulatory approvals will be sought in other nations.
Palovarotene obtained authorisation for usage in Canada and received provisional approval in the United Arab Emirates (UAE) as Sohonos (palovarotene capsules).
Ipsen research and development executive vice-president and head Howard Mayer stated: “We believe that our clinical data provide evidence supporting the effect of palovarotene on the reduction of new, abnormal bone formation, known as heterotopic ossification, which characterises the disease.
“We are therefore disappointed that the European Commission decided not to approve this treatment for patients with FOP in Europe.”
A chronic condition, FOP causes flare-ups which can lead to the formation of abnormal bones.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Indications
Drugs
Chat with Hiro
Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.