Date: 2017-11-23
Type of information: Product launch
Product name: Oxervate® (cenegermin eye drops - recombinant human nerve growth factor)
Compound: recombinant human nerve growth factor
Therapeutic area: Rare diseases - Ophtalmological diseases
Action mechanism:
- protein. Cenegermin is the recombinant version of the human nerve growth factor (NGF) discovered by Nobel Laureate Rita Levi Montalcini. Patients with neurotrophic keratitis have damage to the trigeminal nerve. This results in reduced or lack of sensation in the cornea (the clear layer at the front of the eye), and reduced production of the substances that play an important role in repairing damage and ensuring survival of cornea cells. There is currently no satisfactory treatment for neurotrophic keratitis. Depending on the stage of their disease, patients may be given eye drops to moisten the eye, antibiotics for eye infections, and protective contact lenses. Where appropriate, they may undergo surgery. Administered in the form of eye cenegermin is expected to help restore some of the normal healing processes in the eye and repair the damage to the cornea.
- Cenegermin was developed at the Dompé L’Aquila Research and Production Centre.
Company: Dompé (Italy)
Disease: neurotrophic keratitis
Latest news:
- • On November 23, 2017, Dompé announced that it has launched Cenegermin in Germany. The country is the first market for the therapy’s global launch. This development follows the European Commission’s decision to grant the marketing authorisation of Cenegermin in July 2017 for the treatment of moderate or severe neurotrophic keratitis in adults.
- • On May 18, 2017, the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency has released a positive opinion, recommending the marketing authorization for Oxervate® (cenegermin eye drops), for the treatment of adult patients with moderate or severe neurotrophic keratitis.
- This rare and disabling eye condition can lead to the loss of vision. As of today, no satisfactory treatment is available for this disease. Due to the risks related to this pathology and to the lack of viable therapeutic options, the CHMP completed its review through an accelerated assessment. It began in November 2016.
- CHMP conclusions are based on data from two phase II clinical trials involving 204 patients with moderate and severe neurotrophic keratitis. Both studies have shown that after eight weeks, a higher number of Oxervate® treated patients reached a complete corneal healing vs patients on placebo. The most common adverse reactions observed with Oxervate® include eye pain, eye inflammation, increased lacrimation (secretion of tears), eyelid pain and foreign body sensation in the eye.
- • On November 12, 2015, the Committee for Orphan Medicinal Products (COMP) has recommended the granting of an orphan designation for recombinant human nerve growth factor for treatment of neurotrophic keratitis.
• On June 23, 2014, the FDA has granted the orphan drug status to recombinant human nerve growth factor for treatment of neurotrophic keratitis.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization: 2017-07-06
Favourable opinion UE: 2017-05-18
Favourable opinion USA:
Orphan status USA: 2014-06-23
Orphan status UE: 2015-12-14
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
