The findings unlock the potential $3bn (€2bn) a year lupus market, which while significant for UK drug major GlaxoSmithKline, is potentially transformative for Maryland, US-based HGH.
Systemic lupus erythematosus (SLE) is a complex and chronic autoimmune condition that affects around 5m people worldwide according to recent World Health Organisation (WHO) data.
At present treatment options are limited to corticosteroids and systemic immunosuppressants, whose long term use is associated with a significant range of side effects, such as obesity, increased blood pressure and diabetes.
Additionally, while a number of targeted immunosuppressants were being developed by La Jolla Pharmaceutical, BioMarin and Roche and partner Biogen Idec among others, prior to today’s news about Benlysta none had demonstrated significant therapeutic efficacy.
The latest results, which are from the BLISS-76 Phase III trial, demonstrate that a 10mg/kg dose of Benyslsta, in combination with standard care, improved patient response rates by 43 per cent at week 52, compared with a 34 per cent response rate in placebo.
In a press statement released today, HGS’ CEO H Thomas Watkins said that the BLISS-76 finding confirm the drug’s potential to be the first new SLE treatment in several decades.
“We plan to submit marketing applications in the first half of 2010, following discussions with regulatory authorities in the US, Europe and other regions. We will continue to work with GSK to advance this drug to the market where it may benefit patients with significant need.”
Margaret Dowd, president of the US Lupus Research Institute was similarly upbeat, telling Reuters that: “This is a pivotal moment in lupus research.
“Benlysta represents new hope for the 1.5m Americans with lupus and millions more worldwide who have suffered without a safe and effective treatment for more than 50 years."
The latest findings confirm those reported in July from another Phase III study, Bliss-52, which showed that the drug brought about a 57.6 per cent response rate versus the 43.6 per cent rate seen in the control group.
At the time CCO Barry Labinger said that the drug could earn up HGS and GSK, which each hold a 50 per cent share in the product, could earn up to $20,000 per patient per year.