AnaMar has received orphan drug designations for its systemic sclerosis candidate AM1476 from the FDA and the EMA.

The Swedish biotech is now eligible for several incentives in the two regions, according to the designations. Both agencies will provide regular feedback during the application process and waive certain fees. The FDA also offers seven years of market exclusivity while the EMA promises ten years of protection from competition.

AnaMar’s AM1476 is an oral antagonist of the 5-hydroxytryptamine receptor (5-HT2B) receptor, which is also known as a serotonin receptor. The company says its candidate halts key signalling pathways associated with fibrosis in a 5 February press release.

Systemic sclerosis, also known as scleroderma, is a progressive autoimmune disease characterised by inflammation and fibrosis. Not only is skin hardened in this condition, but internal organs can be affected too. Interstitial lung disease (ILD) is one of the most common disease consequences, occurring in approximately 80% of patients. Though no approved therapies are treating the underlying cause of the disease, the FDA has approved drugs that manage associated complications.

Boehringer Ingelheim’s Ofev (nintedanib) became the first drug available to treat systemic sclerosis-associated ILD when the FDA approved the tyrosine kinase inhibitor in September 2019. Genentech’s subcutaneous injection Actemra (tocilizumab) followed as the first biologic with FDA approval in The market for systemic sclerosis is expected to be worth $2.05bn in 2030, as per GlobalData’s Pharma Intelligence Centre.

source：https://www.pharma-technology.com/news/anamar-secures-double-orphan-drug-designation-for-systemic-sclerosis-drug/