Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) has announced that the Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for TAVALISSE™ (fostamatinib disodium).
Rigel was pleased to make the announcement revealing that the U.S. regulator had accepted its approval application for TAVALISSE. The latter is a drug that the pharmaceutical company has been developing for treating patients suffering from chronic or persistent immune thrombocytopenia (ITP). Rigel expects the FDA to complete the review for the treatment on April 17, 2018 under the Prescription Drug User Fee Act (PDUFA). The company is confident about the fate of the drug especially because the FDA had previously given TAVALISSE an orphan drug designation for treating patients with ITP.
“The FDA acceptance for filing of our NDA is an exciting milestone for Rigel. If approved, we believe TAVALISSE™ will provide a new treatment option for patients with chronic or persistent ITP. We look forward to working closely with the FDA as they review our submission,” stated Rigel’s President and CEO, Raul Rodriguez.
Rigel’s NDA for TAVALISSE includes support from Phase III clinical trial findings for fostamatinib in ITP. The clinical trials included three studies. An open-label extension study (Study 049) and two randomized placebo-controlled studies (Studies 047 and 048). The trials involved 163 ITP patients and company also submitted a proof of concept study to accompany the clinical trial results. Fostamatinib has been closely evaluated in more than 4,600 subjects and data from all the studies including the manufacturing data as well as pre-clinical evaluation was submitted as part of the NDA.
If the drug is approved, Rigel’s new drug will help boost its topline and also strengthen its portfolio of treatments in the market. The company is hopeful that the trial findings will support a positive decision from the FDA, thus it expects a go-ahead for the sale of the drug once the review is complete. The news about the NDA is expected to spearhead positive sentiments from traders about the company’s stock.
Rigel stock closed the latest trading session on Monday at $2.78 after gaining by 11.20 percent compared to the previous close.