HIV Drug Lenacapavir Faces Delay In India: What Patients Need To Know
Lenacapavir is expected to transform HIV prevention significantly. Health experts call it a major step towards controlling the epidemic.
The availability of the breakthrough HIV drug Lenacapavir in India is getting delayed due to regulatory issues and activists have raised concerns over its impact on the people at risk. Activists have warned that even though Indian companies could produce Lenacapavir at low cost, its access remains stalled in India. They said slow regulatory clearances and new patent filings by American drugmaker Gilead are creating major barriers. The concerns were raised ahead of World AIDS Day on Dec. 1.
According to a report by The Hindu BusinessLine, treatment activists argue that even though Indian generic manufacturers can supply Lenacapavir at affordable prices, regulatory delays may slow down the process. Some of them have also legally opposed Gilead’s patent application here.
Lenacapavir is a twice-yearly injectable and could transform HIV prevention. Health experts call it a major step toward controlling the epidemic.
Last October, Gilead Sciences issued voluntary licences for generic Lenacapavir. The licences went to Dr Reddy’s and Emcure and other companies in Egypt and Pakistan. This means that Indian firms can make the drug at low cost, but regulatory delays are slowing progress.
In a letter to the Drugs Controller General of India, the representatives of the Third World Network urged a reconsideration of the SEC’s (subject expert committee) recommendation and asked for a waiver to avoid duplicating global clinical evidence. They said this would speed access where strong foreign data already exists. The letter cited Hetero Labs’ rejected request for a trial waiver, according to the BusinessLine report.
Public health lawyer Leena Menghaney was quoted as saying by the publication that Lenacapavir meets all criteria for such a waiver, yet the authorities have not granted it one.
The report added that India's drug trial rules allow companies to seek local trial waivers if a drug is already approved by regulators such as the USFDA or the European Union’s EMA. Lenacapavir meets this criterion. Moreover, the World Health Organization (WHO) has also endorsed the drug for HIV prevention earlier this year.
Eldred Tellis of the civil society group, Sankalp Rehabilitation Trust, has urged regulators and stakeholders to act quickly so that the long-acting HIV prevention reaches people at risk. His group is challenging Gilead’s India patent, arguing the compound is already known, the report added.
