Clofazimine
Lamprene (generic name clofazimine) manufactured by Novartis, has not been available through traditional pharmaceutical distribution since October 2004. NTMir became aware of this situation when we received urgent calls from NTM patients, their healthcare providers who were notified that they would be unable to obtain the drug for the treatment of Mycobacterium avium-complex (MAC) infections, and by postings on the www.ntminfo.org patient support message board. Resolution of this situation was prioritized by NTMir because we are aware that in some patients with highly resistant MAC, clofazimine provides the only hope for adequate treatment and, in some cases, their survival.
NTMir investigation uncovered the reason that Novartis changed its distribution network and immediately began negotiating access for NTM patients.
In the desire to implement an international compassionate care program Novartis determined with the World Health Organization and the U.S. Department of Health and Human Services (DHHS) that clofazimine would only be available for the treatment of Hansen’s Disease. In addition, a decision was made that Clofazimine would be made available under special circumstances for use in the treatment of multi-drug resistant tuberculosis. Novartis notified physicians and set the date of November 1, 2004 to discontinue distribution to all entities with the exception of DHHS, which was implementing the new program. Novartis was unaware that clofazimine was medically essential in the treatment of MAC in certain NTM patients.
We are pleased to tell you that on behalf of NTM patients, NTMir has facilitated a special relationship with Novartis, the U.S. Department of Health and Human Services, and the U.S. Food and Drug Administration. As of 2005, a simple government program is in place to expedite access to clofazimine for NTM patients. This program will allow healthcare providers treating NTM and specifically Mycobacterium avium-complex infections in HIV seronegative patients to fill out a simple form and receive clofazimine.
The Process to Obtain Clofazimine
The healthcare provider goes through their hospital Independent Review Board and then submits an individual IND to the FDA for the patient requiring the drug.
Required Documents
FDA Forms:
1571
1572
HFD-590
Doctor's CV
Current lab results for the patient (CBC, chem)
Signed informed consent document
IRB approval letter
For your information - Clofazimine Treatment Protocol
You do not need to contact Novartis.
Once you have gone through the IRB and sent your forms to the FDA and you are approved, the clofazamine will be provided to your patient through Hansen's Division/Novartis free of cost - it usually takes about 10-14 days from the time the FDA receives your fax to when the clofazimine arrives.
Fax the forms to:
Ramou Mauer
Phone (301) 796-3928
Fax: (301) 796-9881
You may also need to mail the application to:
Division of Special Pathogen and Transplant Products
Office of Antimicrobial Products
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Building 22, Room 6170
Silver Spring, Maryland 20993
Please read the highlighted paragraph CAREFULLY. We do not have any other information at this time. If you have questions, it is best to contact the FDA at the numbers listed above.
NTMir is dedicated to improving knowledge about NTM disease and to promoting better care through partnerships between patients, providers, industry and government.
We appreciate the opportunity to serve you.
Philip Leitman
President
Miriam O'Day
Senior Director Public Policy
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