Bulevirtide: First Approval
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ADISINSIGHT REPORT
Bulevirtide: First Approval Connie Kang1 · Yahiya Y. Syed1
© Springer Nature Switzerland AG 2020
Abstract Bulevirtide (Hepcludex®), a first-in-class entry inhibitor, is being developed by MYR GmbH for the treatment of chronic hepatitis delta virus (HDV) and chronic hepatitis B virus (HBV) infections. Bulevirtide was recently approved in the European Union (EU) for the treatment of chronic HDV infection in HDV RNA positive adult patients with compensated liver disease. This article summarizes the milestones in the development of bulevirtide leading to this first approval for chronic HDV.
Bulevirtide ( Hepcludex®): Key points An entry inhibitor that is being developed by MYR GmbH for the treatment of chronic HDV and HBV infections. Received its first approval on 31 July 2020 in the EU. Approved for use in chronic HDV infection in HDV RNA positive adult patients with compensated liver disease.
1 Introduction Bulevirtide ( Hepcludex ®; formerly Myrcludex B) is a first-in-class entry inhibitor developed by MYR GmbH for the treatment of chronic HDV and HBV infections [1, 2]. Chronic HDV develops either as co-infection with HBV or as super-infection in patients with chronic HBV. HDV can accelerate hepatitis disease progression and lead to liver cirrhosis and hepatocellular carcinoma [3]. With an increasing Enhanced material for this AdisInsight Report can be found at https://doi.org/10.6084/m9.figshare.12806612. This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through preclinical and clinical studies to market launch and beyond. * Connie Kang [email protected] 1
Springer Nature, Mairangi Bay, Private Bag 65901, Auckland 0754, New Zealand
worldwide prevalence and no cure, treatment options for chronic HDV are an area of unmet need [3]. Bulevirtide inhibits the entry of HDV and HBV into human hepatocytes, leading to recovery and protection of naïve hepatocytes and potential virus eradication [2–4]. Bulevirtide was approved in July 2020 in the EU for the treatment of chronic HDV in HDV RNA positive adult patients with compensated liver disease [2, 5]. The approved dosage of bulevirtide is 2 mg once daily (every 24 h ± 4 h) by subcutaneous (SC) injection as monotherapy or coadministered with a nucleoside/nucleotide analogue for treatment of the underlying HBV infection. Though the optimal treatment duration is unknown, treatment should be continued as long as clinical benefit is evident. As no studies have been conducted with bulevirtide in patients with moderate or severe hepatic impairment, bulevirtide is not recommended in patients with decompensated liver disease [2]. Bulevirtide is currently undergoing phase III development for chronic HDV infection in Germany, USA, Sweden, Italy, Georgia and Russia [6]. The development program for chronic HBV infection is in phase II [6]. The drug is also in phase I stage for dyslipidaemia and in preclinical stage for non-alcohol
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