Gilead Sciences (Nasdaq: GILD) has asked FDA for the second time in a year to approve the capsid protein inhibitor lenacapavir. The drug won Breakthrough Therapy Designation from FDA in 2019 for HIV-1-infected individuals who are heavily treatment-experienced and have resistance to multiple drugs. The designation covered the potential use in tandem with other antiretroviral…
25 promising pipeline drugs
The pandemic has heightened interest in COVID-19 therapies, sometimes stealing attention from other pharmaceutical breakthroughs. But the pandemic has also served as a reminder that investment in new drugs can pay dividends while leading to a greater societal appreciation for the industry. A 2019 study published in International Health concluded that pharmaceuticals that have launched…
Gilead’s lenacapavir shows promise for multi-drug-resistant HIV
Gilead Sciences presented new results from its Phase 2/3 CAPELLA study focused on its investigational, long-acting HIV-1 capsid inhibitor, lenacapavir. The trial, which involved heavily treatment-experienced people with multi-drug resistant HIV-1 infection, showed that lenacapavir had substantial virologic suppression for 26 weeks. In November, the company had announced that 88% of lenacapavir recipients in the…