Sorry, just seeing this thread now. I got the information right from the PR
Press Release
European Commission Designates OMS721 as an Orphan Medicinal Product for Treatment in Hematopoietic Stem Cell Transplantation |
SEATTLE--(BUSINESS WIRE)--Aug. 28, 2018--
Omeros Corporation (Nasdaq: OMER) today announced that the European
Commission (EC) has adopted a decision designating OMS721 as an Orphan
Medicinal Product in the European Union (EU) for treatment in
hematopoietic stem cell transplantation (HSCT). The adoption by the EC
follows a positive opinion for orphan designation of OMS721 in this
indication by the European Medicines Agency’s (EMA) Committee for Orphan
Medicinal Products (COMP). OMS721 is Omeros’ lead human monoclonal
antibody targeting mannan-binding lectin-associated serine protease-2
(MASP-2), the effector enzyme of the lectin pathway of the complement
system. There are three Phase 3 development programs ongoing with OMS721
in each of HSCT-associated thrombotic microangiopathy (TMA), atypical
hemolytic uremic syndrome (aHUS), and immunoglobulin A (IgA) nephropathy.
This represents the second orphan drug designation in Europe for OMS721,
with the first being for OMS721 in the treatment of primary IgA
nephropathy. Orphan drug designation in Europe is available to companies
developing products intended to treat a life-threatening or chronically
debilitating condition that affects fewer than five in 10,000 persons in
the EU. This designation allows for financial and regulatory incentives
that include a 10-year period of marketing exclusivity in the EU after
product approval, protocol assistance from the EMA at reduced
fees during the product development phase, and access to centralized
marketing authorization. OMS721 also has been granted orphan
designations from the U.S. Food and Drug Administration (FDA) for
indications related to both HSCT-associated TMA and IgA nephropathy.
Omeros is in discussions with European regulators and FDA to discuss
full and conditional/accelerated approval for OMS721 in HSCT-associated
TMA.
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