Iluvien close to approval in 10 more EU markets
pSivida (ASX:PVA) licensee Alimera Sciences is close to securing marketing authorisations in 10 more European countries for Iluvien in diabetic macular oedema (DMO).
Alimera’s application through the EU’s Mutual Recognition Procedure (MRP) has entered the national phase in the markets, the companies announced.
During the national phase, each country will grant marketing authorisation for Iluvien as a treatment for vision impairment associated with chronic DMO considered insufficiently responsive to available therapies.
The 10 markets are Belgium, the Czech Republic, Denmark, Finland, Ireland, Luxembourg, the Netherlands, Norway, Poland and Sweden.
The EU’s MRP allows companies to use national authorisation in one member state as a basis for securing authorisation in others.
Alimera first received marketing authorisations in the UK, Austria, France, Italy, Portugal, Spain and Germany. The company has so far launched the product in the UK and Germany.
Alimera has also applied several times for a New Drug Application for Iluvien in the US. The FDA has set the latest PDUFA date at 26 September. If Iluvien is approved in the US, pSivida will receive a US$25 million ($26.5 million) milestone payment as well as a share of the profits from product sales.
pSivida (ASX:PVA) shares were trading unchanged at $4.23 as of around 1 pm on Tuesday.
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