Mytesi
Generic name: crofelemer
Treatment for: Diarrhea
Napo Comments on FDA Announcing Extension of Crofelemer NDA Priority Review
SAN FRANCISCO--(BUSINESS WIRE)--May 3, 2012 - Napo Pharmaceuticals, Inc. (Napo) has been informed that the U.S. Food & Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for the company's first in class novel drug compound, crofelemer. The Agency's Priority Review of the New Drug Application (NDA) for crofelemer is for the indication of chronic diarrhea in people living with HIV/AIDS who are on anti retroviral therapy.
According to Salix Pharmaceuticals, Inc. (Salix), the PDUFA date, which was originally set for June 5, 2012, has been extended to September 5, 2012. The FDA apparently notified Salix that it extended the PDUFA date by three months because it needs additional time to conduct a full review of the NDA. According to Salix, the FDA has not requested additional studies.
Although Salix filed the NDA with the FDA for CRO-HIV, Napo discovered and developed crofelemer and owns all the IP related to the drug. On November 4, 2011, Napo terminated its Collaboration Agreement, dated December 9, 2008, with Salix because Salix breached the agreement. In May 2011, prior to terminating the Collaboration Agreement, Napo filed suit against Salix because of Salix's alleged failure to satisfy its contractual obligations to commercialize crofelemer in a timely manner. Crofelemer has received fast-track designation by the FDA to treat diarrhea in people living with HIV/AIDS.
Despite the announcement of crofelemer's highly statistically significant Phase 3 ADVENT trial results for CRO-HIV on November 4, 2010, Salix did not file the NDA with the FDA for this indication until December 2011 – after Napo filed suit against Salix and served Salix with its notice of termination of the Collaboration Agreement.
“Our company is committed to the advancement of crofelemer,” says Lisa A. Conte, CEO of Napo. “We are optimistic about our ability to bring it to the HIV community and the global marketplace as quickly as possible.” Napo has already invested tens of millions of dollars in the development of crofelemer.
According to the Center for Disease Control, there are 1.2 million people living with HIV/AIDS in the United States, of which approximately 338,000 suffer from chronic diarrhea.
Napo Pharmaceuticals, Inc.
Napo focuses on the development and commercialization of proprietary pharmaceuticals for the global marketplace. The company's business model merges traditional high-value markets in the West with the higher volume business models of emerging and developing economies. Napo's discovery process is based on the knowledge of traditional healers, or shamans, working in rain forest areas and provides benefit sharing to the communities with which it works. Visit Napo at www.napopharma.com.
Contact: R.C. Auletta and Company
Jason Solomon, 212-355-0400
jsolomon@auletta.com
Posted: May 2012
Related articles
- FDA Approves Fulyzaq - First Anti-Diarrheal Drug for HIV/AIDS Patients - December 31, 2012
- FDA Continues Review of Crofelemer New Drug Application beyond PDUFA Goal Date of September 5, 2012 - September 5, 2012
- Salix Pharmaceuticals Announces Extension of Crofelemer NDA Priority Review - April 30, 2012
- Salix Pharmaceuticals Announces FDA Granting of Priority Review Designation for the Crofelemer NDA for Treatment of Diarrhea in Patients with HIV/AIDS on Anti-Retroviral Therapy - February 7, 2012
- Salix Pharmaceuticals Announces NDA Submission for Crofelemer for the Treatment of HIV-Associated Diarrhea - December 14, 2011
Mytesi (crofelemer) FDA Approval History
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