India’s largest drugmaker Sun Pharmaceutical has picked up its first FDA approval for a novel drug, getting the nod for plaque psoriasis therapy Ilumya.
The US regulator has approved Ilumya (tildrakizumab-asmn) for adults with moderate-to-severe psoriasis on the back of clinical trial data comparing the drug against placebo and Amgen’s TNF inhibitor Enbrel (etanercept), a widely-used biologic for the skin condition.
Ilumya isn’t entirely home-grown, as Sun Pharma licensed the interleukin-23 (IL-23) inhibitor for Merck & Co/MSD in 2014, but the green light is a landmark along the Indian company’s journey from being primarily a producer of generic medicines.
The company may find the going tough once it starts commercialising the drug however, as psoriasis therapy has seen a big increase in the number of drugs competing for market share of late. For years treatment for patients requiring systemic therapy has been dominated by TNF blockers such as Enbrel and AbbVie’s Humira (adalimumab), but these are now expected to lose market share to new entrants, and particularly selective interleukin inhibitors, thanks largely to improved tolerability.
Johnson & Johnson’s IL-12/IL-23 blocker Stelara (ustekinumab) was the first interleukin drug to reach the market and swiftly reached blockbuster sales level, and has since been joined by IL-23-selective follow-up Tremfya (guselkumab) as well as three IL-17 inhibitors – Novartis’ Cosentyx (secukinumab), Eli Lilly’s Taltz (ixekizumab) and Valeant Pharma’s Siliq (brodalumab).
Meanwhile, AbbVie has an IL-23 blocker called risankizumab in late-stage testing that it thinks could be a best-in-class treatment and a $1bn-plus contender in psoriasis. With competition heating up – particularly in patients who have already been treated with TNF blockers – analysts have predicted that Ilumya is likely to be a modest product in psoriasis with sales estimates well below $500m a year.
“With the approval of Ilumya and our long-standing commitment in dermatology, we are focused on making a difference for people living with moderate-to-severe plaque psoriasis,” said Sun Pharma’s US president and chief executive Abhay Gandhi.
“We are committed to working with all relevant stakeholders to make Ilumya available to appropriate people with plaque psoriasis,” he added.
Last November, Sun Pharma’s European licensee for tildrakizumab – Spain’s Almirall – said it expects the launch of the drug in the EU to be delayed by at least six months because of regulatory issues. It’s now hoping to make it available around the end of this year or early in 2019.
Almirall licensed European rights to the drug in July 2016 and filed for the regulatory approval with the EMA in March 2017.