skip to main content
Close Icon We use cookies to improve your website experience.  To learn about our use of cookies and how you can manage your cookie settings, please see our Cookie Policy.  By continuing to use the website, you consent to our use of cookies.
Global Search Configuration

Enthusiasm following Benlysta's approval has died down, and there remains a considerable need for effective biologic therapies


With considerable remaining unmet needs for effective biologic therapies, companies developing pipeline candidates for systemic lupus erythematosus (SLE) should consider lessons from Benlysta (belimumab; GlaxoSmithKline) in order to maximize their future commercial potential. As the only biologic to have been approved for SLE in over 50 years, Benlysta is considered the benchmark drug, and key opinion leaders note that new agents in development must demonstrate equal or superior efficacy before they will achieve equivalent uptake with rheumatologists in the US and five major EU markets (France, Germany, Italy, Spain, and the UK). Although the approval of Benlysta was met with widespread enthusiasm, in daily practice only a moderate number of patients fit the criteria for its use. Indeed, the drug is mostly used for maintenance therapy. Furthermore, skepticism still exists, fueled by mixed efficacy and results in practice. Nevertheless, Benlysta has faced little competition as other therapies have so far failed to match its success in Phase III.

 

Following very promising Phase IIb results, anifrolumab (AstraZeneca) has been propelled to the forefront of SLE drug development. AstraZeneca has invested in two large-scale Phase III trials, and if anifrolumab demonstrates similar efficacy in these trials, the company will be able to benefit from a wide open SLE market, with minimal competition in its way. However, numerous promising candidates have previously failed to succeed in Phase III, including Anthera Pharmaceuticals’ blisibimod and Merck KGaA’s atacicept, both of which failed to meet the primary endpoint in their Phase III trials, putting further development of both drugs in jeopardy. As a result, success for anifrolumab is far from guaranteed in this difficult market, until additional data become available.

 

Datamonitor Healthcare’s SLE marketed and pipeline analysis compares the clinical and commercial attractiveness of marketed and pipeline candidates, providing an assessment of future product positioning and competitiveness in the marketplace.

Next steps

Getting a demo tailored to your needs is the best way to see how our solutions will help you gain an advantage.

Request live demo now:

Our team is always happy to hear from you. Please call us at:

  • US Toll-Free  : +1 888 670 8900
  • US Toll           : +1 908 547 2200
  • UK & Europe : +44 (20) 337 73737
  • Australia        : +61 2 8705 6907
  • Japan              : +81 3 6273 4260

Or please submit your inquiry via the form so that we can provide you the best possible customer service.

Have an immediate and specific information need?

Browse and buy from 1000s of analysis and research reports now: