Neurotrofische keratitis: EMA aanvaardt aanvraag verkoopverguning van Dompé voor oogdruppels met Cenegermin (Oxervate®)
MILAAN–(BUSINESS WIRE)– Het biofarmaceutische bedrijf Dompé heeft bekendgemaakt dat zijn verzoek bij het Europees Geneesmiddelenbureau voor de oogdruppels Oxervate tegen matige tot ernstige neurotrofische keratitis is aanvaard.
De aanvaarding door het Europees Geneesmiddelenbureau is het begin van een wetenschappelijk beoordelingsproces van het dossier, met het uiteindelijke doel een vergunning voor de verkoop van het medicinale product te verkrijgen. Het product is in 2015 aangemerkt als weesgeneesmiddel voor de behandeling van neurotrofische keratitis door de Commissie voor Weesgeneesmiddelen van het Europees Geneesmiddelenbureau. Cenegermin, de actieve substantie van het middel, is een recombinante versie van de menselijk groeifactor voor zenuwweefsel, dat is ontdekt door Nobelprijswinnaar Rita Levi Montalcini. Het is een eiwit dat het menselijk lichaam zelf aanmaakt en verantwoordelijk is voor de ontwikkeling, het behoud en de overleving van zenuwcellen.
Neurotrophic Keratitis: EMA Validates the Marketing Authorisation Application for Cenegermin Eye Drops (Oxervate®) Submitted by Dompé |
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MILAN–(BUSINESS WIRE)– The biopharmaceutical company Dompé announced the acceptance of the registration application submitted to the European Medicines Agency (EMA) for Oxervate® eye drops, for the treatment of moderate and severe neurotrophic keratitis in adult patients. Acceptance by EMA constitutes the initiation of the dossier’s scientific review procedure, in order to obtain authorisation to market the medicinal product, which was designated an orphan drug for the treatment of neurotrophic keratitis by EMA’s committee for Orphan Medicinal Products (COMP) in 2015. Cenegermin, the product’s active substance, is the recombinant version of the human nerve growth factor (NGF), discovered by Nobel Prize winner Rita Levi Montalcini. It is a protein produced naturally by the human body and that is responsible for the development, maintenance and survival of nerve cells 2. The investigational medicinal product has been studied in patients with moderate and severe neurotrophic keratitis. Neurotrophic keratitis is a rare degenerative eye disease affecting fewer than 5 in every 10,000 3 people, which causes damage to the corneal epithelium and a loss of corneal sensitivity. In its more severe forms, it can cause corneal ulcers, melting and perforation, with consequences for the visual capacity of those suffering from it 4. A number of different clinical conditions such as viral infections of the cornea 5, eye injuries, chemical burns and lesions, corneal surgery 6, or even systemic conditions such as diabetes 7 can cause the disease. Considering the severity of the condition, the lack of valid treatment options for patients and the innovative nature of the product, at this first stage EMA decided to adopt an accelerated assessment of the dossier. “We are proud to announce such an important breakthrough in our Research & Development pathway. If it is approved, this treatment option will bring benefits to the management of patients suffering from neurotrophic keratitis, by becoming the first biotech product to be developed by Dompé. An accomplishment testament to the passion and commitment of an extraordinary team who has believed in this project since the beginning”, explains Eugenio Aringhieri, Dompé’s Chief Executive Officer. “Our daily commitment has always focussed on finding innovative answers to unmet health needs: we intend to continue providing all the information required by the regulatory authorities, in order to guarantee the availability of the medicinal product as soon as possible.” “Being the first to have brought the nerve growth factor from discovery to a potential future therapy is a further confirmation of the research efforts conducted by us and by the pharmaceutical companies of our country. It is a major achievement that clearly demonstrates Italy’s strengths”, explains Sergio Dompé, Chairman of Dompé. “My thoughts and my thanks at this time go to the whole team of researchers, who have participated in the project at the international level according to their roles, ensuring a significant contribution to the development of this new drug, but especially to Professor Rita Levi Montalcini, whose ingenious intuition paved the way for this research. I am referring to the studies on the nerve growth factor that earned her the Nobel Prize.” About Dompé Dompé is one of the main biopharmaceutical companies in Italy focused on the development of innovative pharmaceutical solutions for diseases with high social impact and which are often incurable. Dompé has its headquarters in Milan and focuses its research efforts in areas with unmet therapeutic needs, such as diabetes, organ transplants, ophthalmology, and oncology. The industrial center in L’Aquila (Abruzzo) houses a biotechnology facility known worldwide for its excellence and develops primary care drugs intended for markets in about 40 countries worldwide. Dompé also has offices in Albania, France, Germany, the United Kingdom, Spain and the United States (New York). Forward looking statements This press release makes reference to certain information that may not coincide with expected future results. Dompé firmly believes in the soundness and reasonableness of the concepts expressed. However, some of the information is subject to a certain degree of indetermination in relation to its research and development activities and the necessary verifications to be performed by regulatory bodies. Therefore, as of today, Dompé cannot guarantee that the expected results will be consistent with the information provided above. 1 M. Sacchetti, and A. Lambiase, Diagnosis and management of neurotrophic keratitis. Clin Ophthalmol 8 (2014) 571-9. View source version on businesswire.com: http://www.businesswire.com/news/home/20161212005584/en/ Contacts Dompé |
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