The FDA Confirms The Completion Of Reasonable Expectation Of Effectiveness (RxE) Technical Section From Jaguar Health Inc (NASDAQ:JAGX)

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The U.S. Food & Drug Administration’s Center for Veterinary Medicine (CVM) says that Reasonable Expectation of Effectiveness (RxE) Technical Section from Jaguar Health Inc (NASDAQ:JAGX) is complete. Thus it is ok to use it as a conditional approval of Canalevia (crofelemer delayed-release tablets). Canalevia is Jaguar’s lead veterinary drug product candidate. It is also an active pharmaceutical ingredient (API), sustainably harvested, isolated and purified from the Croton lechleri tree. The treatment is primarily for chemotherapy-induced diarrhea (CID) in dogs.

Obtaining a conditional approval of a Minor Use in a Minor Species (MUMS) is not a walk in the park. The company ought to have submitted Environmental Impact (EI), Chemistry, Manufacturing, and Controls (CMC). It must also have Target Animal Safety data similar what is required for a new animal drug application (NADA).

Conditional approval for a MUMS-designated drug grants seven years exclusive marketing

Conditional approval (CA-1) results from the review of the application by the FDA. Once granted, the company can commercialize the product as the sponsor continues collecting extensive evidence of efficiency required for an approval of a full NADA. Once the approval is granted, the sponsor is at liberty to exercise seven years of all-inclusive marketing.

The MUMS Act offers help in the development of animal drug intended for a minor use in a major species. The drugs treat illnesses, which occur in limited geographic areas. They are in use in animals such as turkeys, horses, dogs, chicken, cattle, and cats among others.

Jaguar’s human portfolio has been and continues to be the company’s core focus

CID is an interesting model for human product performance according to Jaguar’s president and CEO, Lisa Conte. The company believes that there are unmet medical needs for the treatment of CID in dogs.

Conte says, “Canalevia is an ideal treatment for CID in dogs because of its demonstrated novel anti-secretory mechanism of action.” Apparently, it does not have any considerable effects on normally-functioning intestinal ion channels. Having merged with Napo Pharmaceuticals, Jaguar says that its primary focus is on growing the human portfolio. The merger would be a transformative event given that Napo also has its particular strengths in the industry.

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