The trial included adults with mild to moderate COVID-19 with symptom onset within 5 days of randomization who were at high risk for progressing to severe disease.
Priorix is administered as a 2-dose series (each dose is approximately 0.5mL) via subcutaneous injection.
The application included data from the phase 2 BEYOND study.
The FDA extended the action date by 3 months to allow more time to review additional analyses of data from the Company’s clinical studies.
The study enrolled women who completed the 24-week LIBERTY 1 and 2 studies and the 28-week open-label extension studies, and who met the definition of a responder.
Phexxi is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.
Zuranolone is an investigational oral neuroactive steroid GABA-A receptor positive allosteric modulator.
The approval was based upon a bioavailability study in healthy adults comparing baclofen oral tablets to Lyvispah.
The sBLA is supported by data from the phase 3 PRIME2 and PRIME trials that assessed dupilumab in patients 18 years of age and older with prurigo nodularis.