- Strategic partnership to develop and commercialise emapalumab, a highly attractive late stage orphan drug candidate that addresses a high unmet medical need in primary Haemophagocytic lymphohistiocytosis (HLH)
- Emapalumab provides an attractive near-term commercial opportunity for Sobi with sales potential from 2019 onwards, and with an estimated annual SEK 2.5-3.0 B peak sales potential
- Emapalumab application for US regulatory approval was filed with the FDA in March 2018 with a regulatory decision expected towards the end of 2018. Breakthrough Designation has been granted by the FDA. In Europe, emapalumab has been granted eligibility for the PRIME (PRIority MEdicine) scheme by the EMA. A European filing with EMA is planned later in 2018
- Emapalumab has potential therapeutic value in other serious medical conditions, with studies in secondary HLH and haematopoietic stem cell transplant (HSCT) ongoing or being planned ...
07/20/2018 - 2:30