Catalyst

Slingshot members are tracking this event:

U.S. FDA Approves PREZISTA (darunavir) for Use in Pregnant Women with HIV

Do you think this event is important to the companies below? How will it affect their stock price?

Related Companies
Importance
High Medium Low
Impact on Stocks
JNJ

100%

Additional Information

Clinical Data An analysis of 34 women who received PREZISTA®/ritonavir dosed at either 600 mg/100 mg twice daily or 800 mg/100 mg once daily in combination with a background regimen demonstrated that exposures to PREZISTA® and ritonavir were lower during pregnancy compared with the postpartum period, but were well-tolerated, and virologic responses were preserved throughout the treatment period in both arms.1,2 There were no reports of mother-to-child HIV transmission among the 29 women who continued therapy through delivery.2 Nor were there any new clinically relevant safety findings compared with the known safety profile of PREZISTA®/ritonavir in HIV-1 infected adults. 2In addition, based on prospective reports to the Antiretroviral Pregnancy Registry (APR) (through July 2015) of 532 live births following PREZISTA® exposure during pregnancy, there was no difference in rates of overall birth defects for PREZISTA®compared with the background rate for major birth defects in a U.S. reference population of the Metropolitan Atlanta Congenital Defects Program.2 The prevalence of birth defects was 2.7 percent (95% CI, 1.2-5.1) among infants exposed to PREZISTA®-containing regimens in the first trimester, and 1.5 percent (95% CI, 0.3-4.4) among exposed infants in the second or third trimester.2
http://www.prnewswir...
Slingshot Insights Explained
Catalyst Date
Occurred on:
Jul 18, 2016
Related Projects Image
  • Don’t see a project related to the catalyst you care about?

Related Keywords Prezista, Darunavir, Hiv