Does anyone know if there been other ema approvals that have gone through the oral hearing process?
Item 8.01 Other Events.
In March 2012, we filed a Marketing Authorization Application, or MAA, through the Centralized Procedure with the European Medicines Agency, or EMA, for the marketing approval of BELVIQ® (lorcaserin HCl) in the European Union, or EU. The proposed indication for BELVIQ in the EU is as an adjunct to diet and exercise for weight control in patients over the age of 18 years old who are obese (BMI ³ 30 kg/m2), or are overweight (BMI 27 kg/m2) with associated risk factor(s), such as hypertension, dyslipidemia, cardiovascular disease, type 2 diabetes, or sleep apnea.
We have received the Day 180 List of Outstanding Issues from the EMA’s Committee for Medicinal Products for Human Use, or CHMP. The issues will need to be addressed before the CHMP can recommend BELVIQ for marketing approval in the EU. The major objections relate to previously identified non-clinical and clinical issues, including tumors in rats, valvulopathy and psychiatric events, and the CHMP requests that we further justify BELVIQ’s overall benefit-risk balance taking these issues into consideration.
In accordance with the CHMP’s process, we have been asked to address the issues in writing. The CHMP also plans to consult with independent experts who will provide recommendations on the outstanding issues. In addition to the written response, we have been invited by the CHMP to provide an oral explanation.
The CHMP is expected to reach its final opinion on the BELVIQ MAA by Day 210, which we continue to expect in the first half of 2013.
In April 2012, VVus submitted response to 180 day LOI and was invited to oral. VVus requested additional time for oral hearing. CHMP moved the hearing to September, 2012. In Sept, VVus announced it was likely to be rejected by EMA. In October, 2012, EMA officially rejected Qsivia. That is just one example. I'm trying to find one where oral hearing leads to approval.