- Kitov Pharmaceuticals (KTOV +10%) remains on track to file a New Drug Application (NDA) with the FDA seeking approval of lead product candidate KIT-302 by year end. The company's confidence in the timeline stems from the written minutes from its pre-NDA meeting with the agency.
- The FDA's feedback confirmed that six-month stability data will be acceptable and that an Advisory Committee review will not be required. Kitov also does not see a problem submitting the additional information requested, including market data, medical literature review of amlodipine and celecoxib in animals and the calculation of the primary efficacy endpoint using an alternative math technique, which KIT-302 met.
- Kitov intends to submit its marketing application under the abbreviated 505(b)(2) pathway which, if accepted, will enable approval in 2017.
- KIT-302 is a combination drug that treats osteoporosis-related pain (celecoxib, branded as Celebrex by Pfizer (PFE -0.3%)) and hypertension (amlodipine besylate, branded as Norvasc).