“Gilead’s Hepatitis D Drug Bulevirtide Receives Approval from UK’s NICE”



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“Gilead’s Hepatitis D Drug Bulevirtide Receives Approval from UK’s NICE”



Gilead’s Hepatitis D Drug Bulevirtide Receives Approval from UK’s NICE

Gilead Sciences announced on Thursday that its new drug, bulevirtide, has been approved by the UK’s National Institute for Health and Care Excellence (NICE). Bulevirtide is a treatment for chronic hepatitis D virus (HDV) infection – a serious liver disease that can lead to cirrhosis and liver cancer.

The Importance of Treating Hepatitis D

According to the World Health Organization (WHO), HDV affects an estimated 5-10 million people worldwide, with up to 70% of individuals who have chronic hepatitis B also infected with HDV. Patients with chronic HDV infection have an increased risk of liver fibrosis, cirrhosis, and liver cancer. Until now, there have been no approved therapies specifically for the treatment of chronic HDV.

The Efficacy of Bulevirtide

The approval of bulevirtide by NICE was based on data from two clinical trials, which demonstrated its efficacy in treating HDV. In one trial, 24 weeks of treatment with bulevirtide in combination with pegylated interferon resulted in HDV RNA becoming undetectable in more than 50% of treated patients. In the other trial, 48 weeks of treatment with bulevirtide resulted in HDV RNA becoming undetectable in more than 40% of treated patients. The drug was also well-tolerated by patients in both trials.

What Is Bulevirtide?

Bulevirtide is a first-in-class entry inhibitor that works by preventing HDV from entering liver cells. It is administered once weekly as a subcutaneous injection and is intended for use in combination with pegylated interferon alfa.

Looking Ahead

The approval of bulevirtide by NICE marks an important milestone in the treatment of chronic HDV infection. With no other approved therapies for this condition, bulevirtide represents a significant advance for patients with HDV. Gilead Sciences also announced in its press release that it is planning to submit bulevirtide for approval in other countries, including the European Union and the United States.

Hashtags

#GileadSciences #Bulevirtide #NICE #HepatitisD #LiverDisease #ClinicalTrials #HDVRNA #EntryInhibitor #PegylatedInterferonAlfa #EU #US

Summary:

Gilead Sciences’ new drug, bulevirtide, has received approval from the UK’s National Institute for Health and Care Excellence (NICE) for the treatment of chronic hepatitis D virus (HDV) infection. The drug is a first-in-class entry inhibitor that works by preventing HDV from entering liver cells and is intended for use in combination with pegylated interferon alfa. The approval of bulevirtide marks an important milestone in the treatment of HDV, as there are currently no other approved therapies for this condition. Gilead Sciences is also planning to submit bulevirtide for approval in other countries, including the European Union and the United States. #HEALTH

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