Omeros obtains FDA CRL for narsoplimab BLA for the treatment of HSCT-TMA


(RTTNews) – Omeros Corp. (OMER), a commercial-stage biopharmaceutical company, said on Monday it had received a full response letter or CRL from the U.S. Food and Drug Administration. The LCR is considering its application for a biological license or BLA for narsoplimab in the treatment of thrombotic microangiopathy associated with hematopoietic stem cell transplantation or HSCT-TMA.

In pre-market activity on the Nasdaq, Omeros shares were down about 13.3% to trade at $ 6.70.

Narsoplimab is the first drug candidate submitted to the FDA for approval in HSCT-TMA. It has the Breakthrough Therapy and Orphan designations in HSCT-TMA and IgA nephropathies.

The company noted that patients after hematopoietic stem cell transplantation or HSCT usually have complex clinical outcomes and are often critically ill. HSCT-TMA increases this complexity and worsens the results. In the CSF, the FDA expressed difficulty in estimating the therapeutic effect of narsoplimab in HSCT-TMA and stated that more information will be needed to support regulatory approval.

There were no chemistry, manufacturing and control or CMC, safety or non-clinical issues preventing the approval raised in the CRL.

Omeros said he remains confident in the efficacy and safety data of narsoplimab in HSCT-TMA. The company has worked closely with the FDA on the clinical development plan, including with respect to both the single-arm trial to support approval and the definition of response as the primary endpoint. .

The company plans to request a Type A meeting as soon as possible with the FDA to discuss CSF and determine the fastest route for approval of narsoplimab for the treatment of HSCT-TMA.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Source link

Leave A Reply

Your email address will not be published.