Benlysta® FDA Complete Response Letter Probability?
The FDA had extended its PDUFA deadline for Belimumab decision by 3 months to March 10, 2011. Approval was expected by the end of February 2011 or 4 March based on past 2 years of FDA approvals which were a few days before the due PDUFA deadline. Based on past FDA decisions within the PDUFA deadline, if the approval is not forthcoming before the due date, the decision may turn out to be more delay, negative with a complete response letter. Last year most of the companies with complete response letters announced after the PDUFA date. Benlysta ®(Belimumab) if not approved by 9th March, 2011, then a Complete Response Letter seems to be the most likely outcome. Inconsistent efficacy trends, lower efficacy in the US, European trials, dropout rates 26% in Phase III, lack of efficacy in lupus parameters involved in mortality and morbidity, improvements limited to quality of life functions mainly (not a disease modifying drug), loss of efficacy after 1 year, serious ADRs like infections, cancer, suicides might have derailed FDA approval despite expert panel recommendation for approval. It is always highly risky to predict or anticipate FDA decision in advance and take approval, conditional approval, rejection or CRL as granted! Belimumab (Benlysta, HGSI, GSK) Lupus Review.