“STAT+: FDA OKs generic HIV prevention shot, widening access for lower-income countries”

Key points

• FDA gave tentative approval to Dr. Reddy’s Laboratories for a generic lenacapavir.
• The generic aims to widen access in dozens of low- and middle-income countries.
• Dr. Reddy’s plans to begin shipping the medicine next month.
• The annual cost per person is set at $40, similar to daily tablets.
• Lenacapavir is injected every six months and branded as Yetzugo in the U.S.