MediQuest Therapeutics said Monday that it requested approval by federal regulators of its experimental therapy to treat Raynaud's disease...
MediQuest Therapeutics said Monday that it requested approval by federal regulators of its experimental therapy to treat Raynaud’s disease.
The U.S. Food and Drug Administration must accept the submission before it reviews the drug’s effectiveness.
Even if the FDA agrees to study the therapy — a topical solution that relieves the painful ailment that constricts blood flow to the extremities — the approval process could take several months.
The submission, however, puts the closely held Bothell pharmaceutical company in the small club of Seattle-area companies that have filed a new drug application with the FDA. Others include ZymoGenetics, Immunex, Dendreon and Icos.
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“This is a milestone of noteworthy significance,” said Jack Faris, president of the Washington Biotechnology and Biomedical Association.
Because MediQuest’s therapy would be the first product marketed for Raynaud’s disease, Chief Executive Frederick Dechow said, the company has requested priority approval — a process that can take six months, compared with the standard 10 months.
The company expects a response from the FDA toward the end of June on whether the agency will review the drug and grant expedited approval, he said. MediQuest has asked the agency for permission to name its product “Vascana.”
The company announced encouraging results from a late-stage clinical trial in November.
Some 10 million people have Raynaud’s in the U.S., said Dechow, with about 2.1 million suffering from a severe enough form of the ailment that they seek treatment.
The company estimates an annual U.S. market for its product of about $400 million.
MediQuest, which has about 30 employees, is looking for partners to build up a sales force of 300 to market the product. “It’s not something we can easily do by ourselves,” Dechow said.
Ángel González: 206-515-5644 or email@example.com