Clofazimine is approved for the treatment of leprosy under the commercial name Lamprene, manufactured by Novartis, but it has not been available in U.S. pharmacies since 2004, after marketing was discontinued.
Currently, individuals are able to obtain access to clofazimine for the treatment of leprosy from the National Hansen’s Disease Program. Under certain circumstances, patients may be able to obtain access to clofazimine for the treatment of non-tuberculous mycobacterial (NTM) infections or other infections, uses for which clofazimine does not have FDA approval, from Novartis.
How to Request Clofazimine
Option #1 – For Patients with NTM Who Are Eligible for the Novartis NTM Program
Novartis is the sponsor of a clofazimine expanded access program in the United States for patients 18 years of age or older with NTM infections. The eligibility criteria for the Novartis NTM program can be found at: https://www.clinicaltrials.gov/ct2/show/NCT04334070.
Physicians who believe their patient may qualify for the Novartis NTM program should contact Novartis at 1-888-NOW-NOVA (1-888-669-6682), Monday-Friday, 8:30 am – 5 pm ET.
Option #2 – For Patients Who Are Not Eligible for the Novartis NTM Program
For patients who are not eligible for participation in the Novartis-sponsored NTM expanded access program, FDA may authorize access to clofazimine under a single patient Investigational New Drug (SPIND), provided all the regulatory criteria are met. The healthcare provider works with their local Institutional Review Board (IRB) and submits a SPIND to the FDA for the patient requiring clofazimine treatment. The healthcare provider will also need to contact Novartis in order to receive clofazimine.
Note: Under FDA’s regulations (21 CFR 312.310(a)(2)), FDA may authorize single patient expanded access for a patient only if FDA determines that the patient cannot obtain the drug under another IND or protocol. For example, if a patient is eligible to participate in the Novartis NTM expanded access program, FDA may not authorize expanded access under a single patient IND for that patient.
- FDA Form 3926 or FDA Forms 1571 and 1572 [Note: A letter of authorization is not required from Novartis]
- FDA DAI Single-Patient Clofazimine Request Form (optional, but recommended to aid review of the application)
- Physician Curriculum Vitae (CV) if statement of qualifications are not provided in Box 7 if using Form 3926 or Box 2 if using Form 1572
- Relevant microbiology test results for the patient (isolate identification and sensitivity data)
- An explanation of why the patient is not eligible for participation in the Novartis NTM program
Once the forms have been completed, submit all information to the FDA, Division of Anti-Infectives, via the following email address: DAIP.EIND.SPIND.REQUESTS@fda.hhs.gov
FDA will review the information submitted and determine if an SPIND may be authorized. The requesting physician will be notified about the decision via email. If the SPIND is authorized, the physician will receive from FDA, via email, the SPIND number and a copy of the SPIND Acknowledgement letter. The physician should then follow the steps below under “Process to Receive Clofazimine.”
- Process to Receive Clofazimine from Novartis The treating physician will need to submit the SPIND number, the FDA issued Acknowledgement letter and all refill requests using the Novartis Managed Access Program. For more information and links, please visit https://www.novartis.com/healthcare-professionals/managed-access-programs.
- Novartis will ask the treating physician to sign a Managed Access Agreement and supply a current Medical License prior to shipment of clofazimine. Novartis can provide additional information regarding this agreement.
- Novartis will also request that the treating physician sign a Physician Attestation form for each patient. This form attests that there is IRB approval, that the patient has signed the informed consent document, and that the physician has read and understands the product information and safety reporting responsibilities.
- In addition to the responsibility of treating physicians to submit safety reports to the FDA, Novartis may request that the treating physician provide them with safety reports.
- All refills will be arranged by contacting Novartis directly using the Managed Access Program (see above). Please do not contact the FDA for refill requests.
At the conclusion of clofazimine use (whether because of completion/discontinuation of treatment, if the patient dies, or if you have decided not to treat this patient with clofazimine), please submit a request to withdraw the SPIND, along with FDA Form 1571/1572 or FDA Form 3926. Please include information on the results of the treatment, and the disposition of any unused supplies of the drug. In addition, if treatment is interrupted because the patient experienced an adverse reaction while receiving therapy that leads to discontinuation, we recommend that you follow the patient until the event is resolved, then submit your withdrawal request and include information on the patient and adverse experiences.
Please note Novartis is not responsible for the content of this webpage or website.
Division of Anti-Infectives