Biotech
Friday, June 21st, 2024 4:59 pm EDT
Key Points
- Gilead’s experimental twice-yearly medicine, lenacapavir, demonstrated 100% effectiveness in preventing HIV among approximately 2,000 women in a late-stage trial. This outcome prompted the trial’s independent committee to recommend unblinding and offering the treatment to all participants, distinguishing it from standard daily pills used by others in the study.
- The successful trial marks a significant advancement for Gilead towards introducing a new form of pre-exposure prophylaxis (PrEP), potentially enhancing its HIV business. This development also spurred a 7% increase in Gilead’s stock, reflecting investor confidence in the drug’s potential impact.
- Gilead now plans to replicate these results and expects to share additional data from an ongoing Phase 3 study involving men who have sex with men, potentially paving the way for FDA approval by late 2025. This achievement aligns with broader efforts in the healthcare sector to offer more accessible and convenient HIV prevention options beyond traditional daily pills, aiming to address global HIV incidence rates effectively.
Gilead announced significant success in a late-stage trial for its experimental HIV preventive treatment, lenacapavir, which proved 100% effective among approximately 2,000 women who received the twice-yearly shot. This outcome led an independent data monitoring committee to recommend unblinding the Phase 3 trial and offering the treatment to all participants, surpassing the effectiveness of standard daily pills used by others in the study. The news propelled Gilead’s stock by about 7% on Thursday, marking a pivotal advancement towards expanding its HIV business with a new form of pre-exposure prophylaxis (PrEP). Jared Baeten, Gilead’s vice president of clinical development for HIV, emphasized the importance of providing diverse PrEP options to empower individuals in choosing what suits them best.
Before seeking FDA approval, Gilead plans to replicate these findings, with upcoming data expected from an ongoing Phase 3 study involving men who have sex with men, anticipated by late 2025. More than a decade after Truvada’s pioneering approval as the first PrEP, daily pills have dominated the market, prompting a shift towards longer-acting injections. PrEP is known to reduce HIV risk significantly—by 99% from sexual transmission and 74% from injection drug use when used correctly—but adoption rates in the U.S. remain low, with only a third of eligible individuals benefitting from it, per CDC data.
Advocates and health policymakers view longer-acting options like lenacapavir as crucial for reaching populations averse to daily pills, potentially curbing the spread of HIV, which caused approximately 1 million new infections globally in 2022. Bruce Richman from the Prevention Access Campaign stressed the necessity of aligning preventive measures with diverse lifestyles to effectively combat the epidemic. Since the FDA’s approval of Apretude in 2021—a bi-monthly injectable PrEP—about 11,000 people have opted for this regimen, illustrating a growing acceptance of non-pill forms.
Anticipating a significant market uptake, analyst Brian Abrahams from RBC Capital Markets forecasts peak sales nearing $2 billion for lenacapavir, potentially rivaling Gilead’s Descovy, which generated around $2 billion in revenue last year. Activists have urged Gilead to ensure equitable access to lenacapavir, especially in low- and middle-income countries with high HIV prevalence, addressing concerns over affordability given Gilead’s history with pricing its HIV medications, such as Descovy’s annual list price of $26,000.
In response to these calls, Gilead pledged to provide updates on strategies for enhancing access in regions most affected by HIV, underscoring its commitment to global health equity amid commercial advancements.
For the full original article on CNBC, please click here: https://www.cnbc.com/2024/06/20/gilead-prep-lenacapavir-succeeds-in-phase-3-trial.html
