Regulatory Focus™ > News Articles > UK Patients to get Early Access to Dompé's Oxervate

UK Patients to get Early Access to Dompé's Oxervate

Posted 07 June 2017 | By Michael Mezher 

UK Patients to get Early Access to Dompé's Oxervate

Patients in the UK will get early access to Dompé farmaceutici's neurotrophic keratitis drug Oxervate (cenegermin), the Medicines and Healthcare products Regulatory Agency (MHRA) announced Wednesday.

Neurotrophic keratitis is a rare degenerative eye disease caused by damage to the trigeminal nerve, often brought on by herpetic infections of the cornea or surgery for trigeminal neuralgia or acoustic neuroma which can lead to loss of eyesight.

Oxervate is currently on its way to gain approval in Europe following a recommendation by the European Medicines Agency's Committee for Medicinal Products for Human Use in May, and was designated an orphan product in Europe in 2015.

However, Oxervate will be made available to UK patients ahead of its approval for UK patients with moderate and severe neurotrophic keratitis under MHRA's early access to medicines scheme (EAMS).

MHRA first announced the EAMS program in March 2014 as a means of speeding access to drugs for life-threatening or seriously debilitating conditions with a high unmet need.

According to MHRA, the decision to provide early access to Oxervate was made based on the results of two Phase II studies (NGF0212 and NGF0214), which showed that more patients who received Oxervate achieved complete corneal healing than those in the control group.

The agency also says there are no other available pharmacological treatments that promote corneal healing, and that successful use of Oxervate could reduce the need for surgery in patients.


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