Cenegermin Eye Drops For the Treatment of Neurotrophic Keratitis Receive European Union Approval
Monday, July 24, 2017 | Product Releases
Dompe announced that the European Commission has granted the marketing authorization of cenegermin eye drops for the treatment of moderate to severe neurotrophic keratitis. This makes it the first biotechnological treatment authorized for this specific indication in the European Union, which responds to the needs of patients affected by this rare and severely debilitating eye disease that can cause vision loss.
Behind the development of cenegermin are decades of research in Italy, stemming from the studies of Nobel laureate Rita Levi Montalcini, who discovered the nerve growth factor (NGF). This lead to the collaboration between Dompe and world-renowned centers of excellence in ophthalmology.
"Neurotrophic keratitis is a rare disease that is particularly debilitating, and until now, has been an unresolved health concern for patients. The authorization obtained by the European Commission, after positive opinion received from the EMA CHMP, is a milestone for the patients affected by this disease, for the research in this sector and for our company," Eugenio Aringhieri, Chief Executive Officer of Dompe Pharmaceuticals, said in a company news release. "It is our first biotech drug that was obtained thanks to the work of a skilled and passionate team that has believed in this project from the beginning; and thanks to the constant collaboration with an excellent medical community, which has contributed to the development of the product in its various phases in national and international centres. It is a long, complex yet exciting journey that never ends but begins with this important regulatory step. The next steps will definitely be to make the product available in other areas outside of Europe and in other future indications."
Cenegermin is the name of the primary active ingredient of the drug, and it is the recombinant version of the human nerve growth factor (NGF), developed and prepared through a biotechnological production process unique to Dompe. Cenegermin is a protein that is almost identical to the one that human body produces naturally, which is involved in the development, maintenance, and survival of nerve cells. Administered as eye drops in patients with moderate to severe neurotrophic keratitis, this solution can help restore the normal healing processes of the eye and repair corneal damage.
"There are numerous clinical conditions that can lead to subnormal corneal sensitivity and neurotrophic keratitis due to damage to the rich nerve supply provided to the eye via the trigeminal nerve", Reza Dana, Professor of Ophthalmology at Harvard Medical School, and Director of the Cornea Service and Senior Scientist at the Massachusetts Eye and Ear, Boston, said in the news release. "In the more severe cases, neurotrophic keratitis can lead to ulcers, corneal necrosis and perforation, and visual loss. Considering the possible severity of neurotrophic keratitis, and the lack of good response to standard therapies in many cases, having a valid therapeutic option that can directly promote nerve function is a major contribution to the field and to the community of ophthalmologists, not to mention the many patients suffering from this condition."
Cenegermin was developed at the Dompe L'Aquila Research and Production Centre, thanks to recombinant DNA technology, with the use of bacteria in which a gene (DNA) is introduced that allows the bacteria to produce the human growth factor on their own.
"I think it is a big success to have taken the first nerve growth factor from Rita Levi Montalcini's discovery after so many years of hard work, and turned it into a therapy that is now authorized at the European Union level. It is further confirmation that it is possible to create innovative research in Italy, and that the pharmaceutical sector in our country is globally competitive," Sergio Dompe, President of Dompe Pharmaceuticals, said in the news release. "At this time, my thoughts and gratitude go out to all of the researchers, who have participated in so many countries and in various roles in the project, making an essential contribution to the creation of this new drug, but especially to Professor Rita Levi Montalcini; this research was born out of her brilliant intuition."
The process of registering the drug is underway, also in the United States, where cenegermin is still an investigational product, and where Dompe has started the submission to the FDA of the first part of the registration application (Biologics License Application) through a procedure called "rolling submission." Finally, in Japan, dialogue has begun with the Pharmaceuticals and Medical Devices Agency (PMDA) to define a development plan in the same direction.
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