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Home Industry News Boehringer Ingelheim receives orphan drug designation for leukaemia drug

Boehringer Ingelheim receives orphan drug designation for leukaemia drug

22nd April 2014

Boehringer Ingelheim has been granted orphan drug designation from US and EU regulators for volasertib, a new therapy for acute myeloid leukaemia.

The US Food and Drug Administration and the European Commission have awarded the drug this status in recognition of its promise as a new option for patients who are not eligible for intensive treatment.

Volasertib has shown in phase I/II clinical trials to offer improved survival times for elderly patients when used in combination with chemotherapy. It is currently in phase III development.

Orphan drug designation is awarded to treatments for rare conditions, for which current therapy options are limited. It indicates that regulatory support and incentives will be offered to the company to aid the development and authorisation process.

Professor Klaus Dugi, chief medical officer at Boehringer Ingelheim, said: "In parallel with the ongoing phase III trials, we will work closely with both agencies and hope patients will benefit from our medicine as soon as possible."

This comes after the firm recently announced its financial results for 2013, confirming a 1.4 percent year-on-year increase in net sales on a currency-adjusted basis.ADNFCR-8000103-ID-801713897-ADNFCR

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