Head-to-head trial necessary strategy for Gilead and Galapagos' filgotinib, says analyst

US biotech major Gilead Sciences (Nasdaq: GILD) and co-developer Belgium-based Galapagos (Euronext: GLPG) received a big shock following the Food and Drug Administration’s complete response letter (CRL) for its rheumatoid arthritis (RA) candidate filgotinib earlier this week.

While there has always been concerns surrounding the Janus kinase (JAK) inhibitor’s safety class profile across the immune space, Gilead’s hopes to differentiate the drug as ‘the safest JAK’ due to its lower rate of adverse events from cross-trial comparisons is now dashed by the CRL, which triggered shares to fall by 5% (28% for Galapagos).

Experts interviewed by analytics firm GlobalData have long called for head-to-head studies within the class, and this may be just the strategy that filgotinib needs to quell concerns and bring it back to the lead in terms of safety in minds of stakeholders.