Italian biotech Dompé announced that the US FDA has awarded a voucher under the new Commissioner’s National Priority Voucher (CNPV) pilot program for accelerated review of an application for the company’s intranasal cenegermin-bkbj (recombinant human nerve growth factor). The voucher program is intended to accelerate FDA review of applications, with the goal of a 1-2 month review time.
Dompé says that it intends to use the voucher for a BLA seeking approval for the use of the nerve growth factor nasal spray for the treatment of non-arteritic anterior ischemic optic neuropathy (NAION) and that it intends to conduct pivotal trials for that indication. The company currently markets an opthalmic solution of cenegermin-bkbj called Oxervate for the treatment of neurotrophic keratitis.
Dompé Executive President Sergio Dompé commented, “The CNPV represents a strategic lever to accelerate access to transformative therapies for patients with unmet medical needs as NAION. Building on our pioneering achievement with Oxervate, the first NGF-based therapy approved for neurotrophic keratitis in 2018, we are now advancing a novel, intranasal formulation of NGF (Cenegermin-bkbj) to bypass the blood-brain barrier and redefine possibilities in neuro-ophthalmology.”
Chief Development Officer Ahmed Enayetallah said, “NAION, strongly associated with obesity, cardiovascular disease and an aging population, is the most common acute optic neuropathy in people over 50 and can lead to severe, permanent vision loss. Given this unmet need, we are thrilled by the opportunity to expedite its development and bring potential solutions to patients sooner through the CNPV voucher.”
Read the Dompé press release
