Approval is based on data from two Phase III studies in branch and central retinal vein occlusion (RVO) showing early and sustained vision improvements non-inferior to aflibercept
This product will be manufactured at Lupin’s Nagpur facility in India and will be supplied to low and middle-income countries
The New Drug Application (NDA) includes data from the Phase III studies OASIS 1, 2 and 3 - showing elinzanetant significantly reduced the frequency and severity of moderate to severe vasomotor symptoms over 12 weeks compared to placebo
The inspection scope included 6 separate Biologics manufacturing units comprising 4 Drug Substance and 2 Drug Product manufacturing plants
Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe
The inspection was concluded with two 483 observations
Leqselvi delivered statistically significant efficacy across two Phase 3 clinical trials
The product is bioequivalent and therapeutically equivalent to the reference listed drug
The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ - II, India
The inspections concluded with no Form 483 observations or significant critical findings
Subscribe To Our Newsletter & Stay Updated
