UNITED KINGDOM — GSK has announced that it would not pursue regulatory approval for its experimental treatment for moderate-to-severe Rheumatoid Arthritis (RA) after the drug failed to meet a key goal in a study.
The antibody-based drug otilimab did not make a significant difference in improving swelling and tenderness in joints to aid movement in patients who had previously not responded to other forms of treatment in a late-stage study.
Following disappointing clinical trial results, GSK Plc has decided not to submit an experimental rheumatoid arthritis therapy to regulators.
While two other trials were successful, GSK stated on Thursday that “the efficacy demonstrated is unlikely to transform patient care.”
“The limited efficacy demonstrated does not support a suitable benefit/risk profile for otilimab as a potential treatment for RA,” said GSK.
GSK licensed otilimab from German biotech MorphoSys in 2013 in a deal valued at up to €423 million (US$421.5 million) including around €23 million (US$22.9 million) upfront.
Analysts surveyed by Bloomberg expected the drug to generate annual sales of €470 million (US$473 million) in 2026.
GSK also tested the medicine in Covid-19 patients with severe pulmonary disease, and it only showed promise in the elderly.
The FTSE 100-listed company also announced that it is one step closer to receiving approval for its first new drug since its consumer health spin-off in July, with an expert panel of the Food and Drug Administration supporting approval for daprodustat – its drug aimed at treating anemia in certain patients with chronic kidney disease.
The FDA has already rejected two other drugs in the same HIF-PHI class, namely FibroGen and AstraZeneca’s roxadustat and Akebia’s vadadustat, citing safety concerns, so the recommendation for approval in dialysis patients is a plus for GSK.
The non-dialysis segment, on the other hand, is critical to GSK’s hopes for £500 million (US$580.7 million) to £1 billion (US$1.2 billion) in peak sales for the drug.
Daprodustat has already received regulatory approval in Japan, where it is marketed as Duvroq, and roxadustat has also received approval in Europe and Japan as Evrenzo.
In a week that saw multiple disappointments in other R&D projects, the EMA has given GSK some good news on a new long-acting HIV drug and vaccine for respiratory syncytial virus (RSV).
The EU regulator has formally begun an accelerated evaluation of GSK’s RSV vaccine for older adults, with a decision now expected in the third quarter of next year – a timeline that could allow GSK to beat rival RSV shot developers, including Pfizer, to the European market.
In addition, the EMA has begun its review of the long-acting drug cabotegravir as an injectable for HIV pre-exposure prophylaxis (PrEP) dosed six times a year following an induction regimen, throwing the gauntlet down to market leader Gilead Sciences.
The two developments provide some relief to GSK after a string of negative pipeline news in recent days that has blown a large hole in sales projections made last year.
These developments have increased the pressure on other projects, particularly GSK’s RSV vaccine, to deliver quickly.
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