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EC grants MSD’s Prevymis orphan product designation

The product will gain some market exclusivity benefits in CMV infection

MSDThe European Commission has granted Merck Sharp & Dohme’s new CMV prevention medication orphan medicinal product status, handing it a package of benefits that will include some market exclusivity.

The status for Prevymis’ (letermovir) covers the prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT).

CMV infection is a common, clinically significant complication in patients taking an immunosuppressant medication as part of a HSCT regimen, which is a life-saving treatment for more than 70 different diseases including leukaemia, lymphoma and sickle cell anaemia.

The EC’s decision came on the back of phase III data showing that after 24 weeks following a transplant, only 37.5% of patients on letermovir developed a CMV infection compared to 60.6% patients on placebo.

The treatment - which MSD acquired from German biotech AiCuris - has already been approved for use in the same disease indication for the US last year.

Around the same time, Prevymis also gained a positive opinion from the Committee for Medicinal Products for Human Use, which gave the approval for the treatment to be used as both as an injectable and tablets.

Louise Houson, UK managing director of MSD, said: “MSD is delighted that the EC has recognised the potential of letermovir for prophylaxis of CMV reactivation in certain patients in need of a new option.”

According to the NHS, approximately 50-80% of adults in the UK are thought to have CMV, and once infected it can persevere in the body as an inactive or latent state.

However the first-in-class antiviral drug inhibits viral replication by specifically targeting the viral terminase complex.

Houson continued: “This authorisation brings us a step closer to making letermovir available in the UK and we will continue to work closely with NICE, NHS, SMC and other relevant stakeholders to help ensure that appropriate patients have access to letermovir as soon as possible.”

Article by
Gemma Jones

31st January 2018

From: Regulatory



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