Johnson and Johnson (NYSE:JNJ)/Janssen Biotech’s Stelara (ustekinumab) has questionable Crohn’s Disease uptake prospects as experts debate the extent of anti-TNF therapy refraction and failure. Most added, however, real-life outcomes should better trial data, potentially boosting its uptake over the poorly responded to agent Takeda Pharmaceutical’s (TYO:4502) Entyvio (vedolizumab).
On 20 April, this news service reported Stelara has promising FDA and EMA approval prospects ahead of its likely 3Q16 verdicts. Experts are optimistic despite underwhelming Phase III efficacy, however, a case of Listeria prompts likely postmarket infection trials.
Analysts predict peak sales forecasts of up to USD 800m.
Stelara achieved statistically significant clinical remission in its two completed 12 week Phase III UNITI-1 (NCT01369329) and UNITI-2 (NCT01369342) trials. The third ongoing maintenance study (NCT01369355) will be presented at the 21-24 May Digestive Disease Week in San Diego, California, said a Janssen spokesperson.