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Shire seeks approval for novel dry-eye treatment

The rare disease specialist has submitted lifitegrast to the European drugs regulatory body
August 17, 2017

Specialising in rare diseases means Shire (SHP) is able to speed through its pipeline of new drugs quicker than many rival pharmaceutical companies. Its latest progression is the application of its novel dry-eye treatment lifitegraft with European drugs regulators. The drug is already approved in the US under the brand name Xiidra where analysts think it could reach peak sales of $1.2bn (£0.93bn). Similar patient numbers and a lack of alternate options means sales could also be strong in Europe.

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The UK’s drugs regulatory body has validated the application, meaning it will evaluate data from five clinical trials – the largest development programme for a dry-eye disease drug candidate – on behalf of 12 European countries. Approval, which is expected in the second half of 2018, would make it the first drug in Europe to address both the signs and the symptoms of dry-eye disease.