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Press Release

MSD Receives Positive CHMP Opinion for PREVYMISâ„¢ (letermovir) in the European Union

MSD
Posted on: 13 Nov 17

Hoddesdon, UK, 13th November 2017 – MSD (Merck & Co., Inc., Kenilworth, NJ, USA) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of letermovir for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT).1

 

Prof. Karl Peggs, Honorary Consultant in Haematology/Transplantation at UCL Hospitals, comments "I am encouraged to hear that letermovir has been granted a positive CHMP opinion. For far too long we've been trying to juggle the toxicities of older drugs. Letermovir offers an opportunity to reduce the CMV-related treatment burden. This is great news both for the treating physicians and the patients we treat."

 

“For patients undergoing an allogeneic haematopoietic stem cell transplant, complications arising from cytomegalovirus infection can be life threatening,” said Dr Mike England, MSD UK Medical Director. “We are pleased with the CHMP’s positive opinion recommending the marketing authorisation of letermovir in the European Union, which marks a significant step forward in the regulatory process as we hope to bring this product to patients in the United Kingdom.”

The CHMP positive opinion will be considered by the European Commission. If the European Commission affirms the CHMP opinion, it will grant a centralised marketing authorisation with unified labelling that is valid in the 28 countries of the European Union, as well as European Economic Area members, Iceland, Liechtenstein and Norway.

 

Pending receipt of marketing authorisation, letermovir will be made available as a concentrate for solution for infusion and as film-coated tablets (240 mg and 480 mg).1

 

The U.S. Food and Drug Administration approved letermovir once-daily tablets for oral use and injection for intravenous infusion in November 2017.

 

ENDS.

 

Media contacts:

Mark Johnson (MSD)

Tel: 01992 452 767

E-Mail: mark.johnson1@merck.com

 

 

 

Elspeth Houlding (Red Consultancy)

Tel: 020 7025 6564

E-Mail: Elspeth.Houlding@redconsultancy.com

 

About letermovir

Letermovir is a member of a new class of non-nucleoside CMV inhibitors (3,4 dihydro-quinazolines) and inhibits viral replication by specifically targeting the viral terminase complex. Letermovir has no activity against other viruses.1 Letermovir has been granted orphan designation for the prevention of CMV disease in at-risk populations in the United States (U.S.), EU and Japan and is under accelerated review in Japan.

Under an agreement signed in 2012, MSD (through a subsidiary) purchased worldwide rights to develop and commercialise letermovir from AiCuris GmbH & Co KG (www.aicuris.com).

 

About CMV infection

CMV is a common virus that infects people of all ages. Many adults are CMV seropositive, meaning they have CMV antibodies in their blood, indicating a previous exposure to or primary infection with CMV. People with normal immune systems rarely develop CMV symptoms after initial infection, with the virus typically remaining inactive or latent in the body for life. A weakened immune system may give the virus a chance to reactivate, potentially leading to symptomatic disease or a secondary infection due to other pathogens. CMV disease can lead to end-organ damage, including gastrointestinal tract disease, pneumonia or retinitis. HSCT recipients who develop CMV infection are at increased risk of serious complications or even death. 2,3

In 2014, there were 1,346 non-paediatric allogeneic HSCT procedures performed in the UK.3 Up to 50% of CMV seropositive recipients of allogeneic HSCT experience CMV reactivation, regardless of the donor’s serostatus.3

 

About MSD

At MSD, we believe the most important thing we make is a difference. We operate in more than 140 countries and through our prescription medicines, vaccines, biologic therapies, and animal health products we work with customers to bring innovative healthcare solutions to those who need them the most. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programmes and partnerships. For more information visit www.msd-uk.com. The company is known as Merck & Co., Inc., Kenilworth, NJ, USA in the United States and Canada. Everywhere else, we are known as MSD.

 

Forward-Looking Statement

This news release of MSD (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialise, actual results may differ materially from those set forth in the forward-looking statements.

 

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

 

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2016 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

 

 

References

1. EMA Summary of Opinion, Letermovir (2017), available at: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/004536/WC500238077.pdf [Accessed 13 Nov. 2017]

 

2. Nice.org.uk. (2017).[online] Available at: https://www.nice.org.uk/guidance/gid-ta10195/documents/draft-scope-pre-referral [Accessed 13 Nov. 2017].

 

3. NIHR, Letermovir for the prevention of cytomegalovirus infection in sero-positive patients undergoing allogeneic haematopoietic stem cell transplantation (April 2016), Available at: http://www.io.nihr.ac.uk/topics/letermovir-for-the-prevention-of-cytomegalovirus-infection-in-sero-positive-patients-undergoing-allogeneic-haematopoietic-stem-cell-transplantation/ [Accessed 13 Nov. 2017].  

 

Editor's Details

MSD
Red Consultancy
elspeth.houlding@redconsultancy.com

Last updated on: 13/11/2017

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