GSK, Genmab seek first-line CLL use of Arzerra in EU

GlaxoSmithKline CEO Andrew Witty

GlaxoSmithKline ($GSK) continues to seek a bigger market for its targeted leukemia drug Arzerra, which it picked up in its $2.1 billion licensing deal with Genmab three years ago but which so far has underperformed. GSK and partner Genmab are asking the European Medicines Agency (EMA) to approve it as a first-line use against chronic lymphocytic leukemia (CLL).

Arzerra has not yet been approved anywhere for a first-line use, but the companies believe new data will boost its chances. It is asking for it to be used in combination with an alkylator-based therapy in patients for which a fludarabine-based therapy is not appropriate. The companies point out that CLL is the most common form of leukemia in adults, with an estimated 11,000 new cases a year in Europe and about 15,680 new cases in the U.S.

Developed with Genmab, Arzerra last year sold less than $100 million, held back by so far only being approved for a second-line therapy in the U.S. and Europe. The FDA last month did grant it a breakthrough designation which speeds up the approval process for drugs with potential for serious and life-threatening diseases and so will fast-track its application in the U.S. for a first-line use.

GSK could use a boost. CEO Andrew Witty has been assuring investors there are better days to come, even as it looks towards new generic rivals for its blockbuster respiratory treatment Advair. It has had some successes of late, with an FDA approval for the lung drug Breo Ellipta and an FDA advisory panel's backing for another Advair follow-up, Anoro. Its ViiV Healthcare joint venture nabbed approval for a potential blockbuster HIV drug, Tivicay.

But the company also has been embattled by a probe into allegations that it used a $490 million slush fund in China to bribe doctors and hospital officials to buy its drugs. Recent estimates have suggested its sales in that country, once one of the highlights of its earnings reports, may take a 30% hit in the third quarter. It has admitted some mistakes there and promised to cut some drug prices to make amends. But the probe has also set into action FDA authorities who want to know if the company violated U.S. foreign corruption laws as a result of what happened in China.

- here's the release

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