MAIA Pharmaceuticals, NJ based specialty pharmaceutical company asserted tentative approval of Sincalide for Injection NDA by the U.S. Food and Drug Administration.
As far as 2013 is concerned, there were over 648,000 patients where KINEVAC was used to stimulate gallbladder contraction. Until now, KINEVAC was the only drug approved by FDA for stimulation of gallbladder contraction and other indications. Over the past 5 years, KINEVAC has often been unavailable to patients and prescribers, causing it to be repeatedly listed on the FDA Drug Shortage List.
MAIA’s Sincalide for Injection is a new and innovative formulation of sincalide that addresses the recurrent shortages of KINEVAC as well as KINEVAC’s shelf-life issues. Recognizing the shortages of KINEVAC and the unmet medical need, the FDA granted “Priority Review” to MAIA’s NDA.
Dr. Srikanth Sundaram, President and CSO of MAIA said “We are pleased to have received this Tentative Approval for Sincalide for Injection. This is a huge step towards getting patients access to a drug that has been plagued by recurrent supply issues for many years forcing practitioners to rely on less than desirable alternatives to address their need which include using preparations from compounding pharmacies or alternate therapies, which are not approved by the FDA. We hope to restore a consistent supply of a stable product, for which there is a clear unmet and public health need.”