- The FDA approval of Sanofi (PA:SASY) (SNY -0.1%) and Regeneron Pharmaceuticals' (REGN) Kevzara (sarilumab) to treat rheumatoid arthritis (RA) is just the first hurdle in its expected march to blockbuster status.
- FiercePharma's Tracy Staton writes that the field is already hotly contested, led by AbbVie's Humira, Roche's Actemra and, shortly, GlaxoSmithKline and Johnson & Johnson (NYSE:JNJ)'s sirukumab (FDA decision expected next quarter).
- The entrenched nature of the leaders is the overriding reason that Kevzara is priced at $39K, lower than the two leading TNF-alpha drugs.
- Kevzara is an IL-6 inhibitor which bodes well for its long-term fit in the treatment paradigm according to Sanofi's Jonathan Sadeh. He says RA is commonly diagnosed in the middle-aged which means they need treatment over decades. First-line therapy, typically a TNF, loses its effectiveness over time so the doctors should switch to a drug with a different mechanism of action.
- The challenge for Sanofi and Regeneron is convincing physicians that Kevzara should be used as first-line instead of second, third or fourth line. This was the motivation behind the head-to-head study with Humira which showed the superiority of Kevzara.
- Sadeh adds that Kevzara has shown that it stalls the progression of joint damage as determined by radiographic imaging, a key selling point.
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Original article