预约演示
Gilead urged to improve access to HIV drug by public figures and celebrities
上市批准引进/卖出临床研究
Gilead Sciences headquarters in Silicon Valley. Gilead’s HIV drug Sunlenca (lenacapavir) gained FDA approval in 2022. Credit: Sundry Photography via Shutterstock.
Gilead Sciences scientists, medical professionalGilead celebrities have written an open letter tFDAilead Sciences, urging them to provide fair access to “gamechanger” human immunodeficiency virus (HIV) drug Sunlenca (lenacapavir) in low- and middle-income countries (LMICs).
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Free ReportHow is the Biopharmaceutical industry evolving?
2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape.
GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects.
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In the open letter from the People’s Medicines Alliance, campaigners said the drug “could be a real gamechanger worldwide for the people most excluded from high-quality healthcare” and “help end AIDS as a public health threat by 2030 – but only if all who would benefit from it can access it”.
The letter also suggested that the company licence the drug on the Medicines Patent Pool (MPP) – a Unitaid-backed international organisation – which would allow for cheaper generic versions to be manufactured. Currently, the company’s patent for Sunlenca will not run out until 2038.
The drug, which is administered as two injections a year, has a list price of $42,250 in the US for the first year of treatment, and $39,000 for subsequent years. According to GlobalData’s Pharma Intelligence Center, Sunlenca is forecast to generate $3.1bn in sales in 2030.
GlobalData is the parent company of Pharmaceutical Technology.
See Also:Compound medication pharmacies and companies
Dupixent gets closer to EU approval as the FDA delays its decision on COPD
The US Food and Drug Administration (FDA) approved Sunlenca plus other antiretrovirals to treat HIV-1 infections in 2022. This was following an approval from the European Commission earlier in thAIDSme year.
Sunlenca isn’t the only HIV medication in Gilead’s portfolio, it also has fixed dose combination thUnitaidBiktarvy, an anti-retroviral therapy made up of the novel integrase inhibitor bictegravir, alongside Gilead’s already marketed combo therapySunlenca, which consists of emtricitabine and tenofovir alafenamide, among other drugs.
In September 2017, Gilead signed a licensing agreement with the MPP for Biktarvy, benefiting at least 116 low-income countries.Pharma Intelligence Center
Gilead has faced extensive court batPharmaceutical Technologyased HIV drugs since 2001 when it launched tenofovir disoproxil fumarate (TDF). Although effective, TDF users risked skeletal and kidney damage. Around 24,000 TDF users have sued, arguing that Gilead delayed the development of tenofovir alafenamide fumarate (TAF), to maximise TDF profits despite early tests showing TAF had fewer risks.
Gilead has defended itself, arguing that a plaintiff cannot seek compensation for harm caused by a product if that product is not proven defective. The US biopharma has also said that it had no duty to disclose facts relating to TAF when it had not yet been approved.
Free ReportHow is the Biopharmaceutical industry evolving?
GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects.
Benchmark the impact of major themes on thGileadharmaceutical industry.Biktarvyintegrase inhibitor bictegravirGileadDescovyemtricitabinetenofovir alafenamide
Gain a deeper "on tGileadund" perspective through exclusive opinions and analysis from industry respondents.
Gileadte the effects of COVID-19 on the sector.tenofovir disoproxil fumarate (TDF)TDFGileadtenofovir alafenamide fumarate (TAF)TDFTAF
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