Alexza Pharmaceuticals disclosed that In September, it received the Day 180 List of Outstanding Issues from the CHMP regarding Adasuve. However, the Day 180 List of Outstanding Issues included two "major objections," which preclude a recommendation for marketing authorization at the present time. The first major objection states that the CHMP does not believe that the company's data supports the broad indication as submitted, and that it should justify that the benefit/risk is positive in this group or identify a group of patients in whom the benefit/risk would be positive. The second major objection is that to limit the risk for bronchospasm and an effect on cardiac rhythms, the company proposed to limit the use of Adasuve to a single dose per 24 hours, however, a "considerable proportion," as described by the CHMP, of patients in the efficacy studies did not respond to a single dose at the 4 hours time point and needed subsequent doses. During Q4, Alexza said it plans to submit additional analyses and responses to the EMA in response to the Day 180 List of Outstanding Issues, including the two major objections.
- Pharmaceuticals & Drug Trials