Generic Version of HIV Drug Recommended for EU
The European Medicines Agency (EMA) has given a positive opinion to a generic medicine, emtricitabine/tenofovir alafenamide, for the treatment of adults and adolescents infected with HIV type 1 (HIV-1).
The EMA's Committee for Medicinal Products for Human Use (CHMP) said that the combination is a generic of the branded medicine Descovy, which has been authorized in the EU since April 21, 2016. The two active substances are antivirals that exert their effects by inhibiting HIV reverse transcriptase through incorporation into the viral DNA, resulting in chain termination.
Studies have demonstrated the satisfactory quality of emtricitabine/tenofovir alafenamide, CHMP said, and its bioequivalence to the reference product Descovy. Like Descovy, emtricitabine/tenofovir alafenamide is indicated in combination with other antiretroviral agents for the treatment of adults and adolescents aged 12 years or older with body weight at least 35 kg, who are infected with HIV-1.
The drug is an oral medication available as 200 mg/25 mg and 200 mg/10 mg film-coated tablets to be taken once daily. The most common side effects include nausea, diarrhea, headache, dizziness, depression, fatigue, insomnia, strange dreams, stomach pain, weight loss, and rash.
Therapy should be initiated by a physician experienced in the management of HIV infection.
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorization has been granted by the European Commission.
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These forward-looking statements are not guarantees of future performance; rather they are based on the Management's current expectations and assumptions about future events and trends, the economy and other future conditions. The forward-looking statements involve a number of known and unknown risks and uncertainties. These risks and uncertainties and other factors could materially adversely affect the outcome and financial effects of the plans and events described herein. The Company's results of operations, cash needs, financial condition, liquidity, prospects, future transactions, strategies or events may differ materially from those expressed or implied in such forward-looking statements and from expectations. As a result, no undue reliance should be placed on such forward-looking statements. This press release does not contain risk factors. Certain risk factors that may affect the Company's future financial results are discussed in the published annual financial statements of the Company. This press release, including any forward-looking statements, speaks only as of the date of this press release. The Company does not assume any obligation to update any information or forward-looking statements contained herein, save for any information required to be disclosed by law. For more information, please contact: Investor ContactsVivoryon Therapeutics Manuela Bader, Director IR & CommunicationEmail: IR@ LifeSci AdvisorsSandya von der Weid Tel: +41 78 680 05 38Email: svonderweid@ Media ContactTrophic CommunicationsValeria Fisher or Verena SchossmannTel: +49 175 8041816 / +49 151 219 412 77Email: vivoryon@ Attachment 20250606_ERA_VVYSign in to access your portfolio
