Omeros’ narsoplimab receives positive opinion from european medicines agency for pediatric investigation plan required for maa submission
Omeros corporation announced that the pediatric committee (pdco) of the european medicines agency (ema) has issued a positive opinion for the company’s pediatric investigation plan (pip) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (hsct-tma). narsoplimab, also referred to as oms721, is omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (masp-2). acceptance of the pip paves the way for submission under the european commission’s centralized procedure of a marketing authorization application (maa) for narsoplimab in the treatment of hsct-tma. a pip outlining a development program for the investigational product in the pediatric population must be agreed with pdco as a prerequisite to ema’s acceptance of an maa. the narsoplimab pip provides a study plan to evaluate the safety and effectiveness of the drug for hsct-tma in patients from 1 month through 17 years of age. omeros received a deferral for completion of its pediatric plan until after ema approval of the narsoplimab maa. with successful completion of the pip, narsoplimab would be eligible for up to an additional two years of marketing exclusivity. in addition to its planned maa, omeros recently initiated the rolling submission of its biologics license application (bla) to the u.s. food and drug administration (fda) for narsoplimab in hsct-tma. omeros will work with fda to allow the same study plan outlined in the pip to form the basis for a written request from fda to extend marketing exclusivity for narsoplimab under the best pharmaceuticals for children act. successful completion of the pediatric plan would add up to six months to the longest applicable u.s. non-patent exclusivity period. narsoplimab has orphan drug designation in both the u.s. and in europe for hsct-tma and has breakthrough therapy designation (btd) in the u.s. narsoplimab also has been awarded btd for immunoglobulin a nephropathy (igan), and phase 3 programs for narsoplimab are ongoing in igan and atypical hemolytic uremic syndrome.
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