Increased Transparency in Decision-making for Orphan Medicines

• 18/01/2018
• Articles

On 17 January 2018, the European Medicines Agency (“EMA”) announced that it would start publishing an “orphan maintenance assessment report” (“OMAR”) for every medicine designated as an orphan medicine during its development. The OMAR would show whether in the EMA’s view the product still satisfies the conditions for being classified as an orphan medicine at the time of its marketing authorisation. The OMAR will be made available as part of a medicine’s European Public Assessment Report (“EPAR”).
 
The OMAR will describe the orphan condition and its seriousness, the spread of the condition at the time of maintenance of the designation, and, if applicable, the significant benefit over already authorised medicines.
 
More details on the EMA’s new approach can be found here.
 
To illustrate all of this, the EMA has already published its first OMAR which covers Prevymis® (letermovir), a medicine whose marketing authorisation is in the hands of Merck. Prevymis® is an antiviral for systemic use indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT).

More information on Prevymis® and its OMAR can be obtained via this link.