* Daprodustat helped improve haemoglobin levels in studies
* Medicine did not increase risk of cardiovascular
complications
* Rival drug roxadustat did not get favourable U.S. opinion
(Adds detail, exec comment, background)
July 16 (Reuters) - GSK said on Friday its anaemia
drug for patients with kidney disease succeeded in late-stage
trials, marking an important milestone for the British drugmaker
as it bolsters its pipeline ahead of a split with its consumer
healthcare venture.
The drug, daprodustat, improved haemoglobin levels in
patients who had not received any standard care, and helped
maintain the levels in those who did, results from five late
stage studies by the company showed.
Daprodustat belongs to a new class of medicines that works
by copying the body's response to hypoxia, or low oxygen levels,
and boosts production of red blood cells by mimicking the body's
response to high altitude.
A rival drug roxadustat, developed by AstraZeneca
and Fibrogen, works just like GSK's treatment. It won
its first regulatory nod in China in late 2018, but a panel of
U.S. experts voted against its approval on Thursday.
Anaemia is a condition in which the number of red blood
cells, or haemoglobin concentration within them, is lower than
normal, and can commonly affect patients with kidney disease.
GSK said studies showed also that daprodustat did not
increase the risk of potentially deadly cardiovascular
complications like heart attacks and strokes compared to
standard treatment for anaemia associated with kidney disease.
The positive results come as a boost for CEO Emma Walmsley,
whose strategy for the global company has been criticized by
activist investor Elliott. Walmsley has made a string of
leadership changes in a bid to boost GSK's drug development
success rate, where the group had fallen behind peers.
"We will continue to analyse the data ... and look forward
to working closely with regulators as we plan for our
submissions," GSK's Chief Scientific Officer, Hal Barron said.
Daprodustat, approved only in Japan for use in patients with
renal anaemia, was also well-tolerated in both dialysis and
non-dialysis patients, GSK said.
Detailed results from the studies will be presented at a
medical conference later this year, it added.
(Reporting by Yadarisa Shabong, Sachin Ravikumar and Pushkala
Aripaka in Bengaluru; Editing by Rashmi Aich and Louise Heavens)