After ASTMH was informed by a member that a process for physicians to access Glucantime was unclear, the Society worked with the Clinical Group subgroup and contacted key individuals for help. With their dedicated and collective assistance, we are pleased to announce the process to acquire Glucantime. See below.
Glucantime (Meglumine antimoniate) is a 1.5g/5ml solution for injection, with 0.4050g of antimony per 5ml ampoule. It is indicated in the treatment of visceral leishmaniasis (Kala-azar) and cutaneous leishmaniasis, except for resistant L. aethiopica. Consultation with a leishmaniasis expert is advised to discuss dosing and duration of treatment.
In order to acquire Glucantime from Sanofi, an individual IND from FDA will be required. Reach out to FDA and Sanofi simultaneously, as each will request information from the other. Both the FDA and Sanofi are attending to these inquires promptly.
Process for requesting Individual IND from FDA
1. Email the Division of Drug Information at FDA: [email protected]; or call the CDER’s Division of Drug Information (DDI) at phone: 301-796-3400 or 855-543-3784; fax: 301-431-6353 during normal business hours from 8am-4:30pm ET weekdays.
2. Provide the information requested for clinical team review, described at Physician Request for a Single Patient IND for Compassionate or Emergency Use | FDA (brief clinical history, relevant lab data, proposed treatment plan, current CV, informed consent statement with approval of Institutional Review Board, etc.)
3. Sign and date FDA Form 3926: Individual Patient Expanded Access Investigational New Drug Application (see link below). The FDA will review the information and reach out to provide the IND number Division. Review will be performed by the Infectious Disease Review Division: Anti-Infectives or Antivirals (contact information provided upon request by the FDA).
|Process for requesting Glucantime from Sanofi website
1. Go to Sanofi’s Managed Access Programs (MAPs) website Managed Access Programs (MAPs) - Sanofi
2. Scroll down to the Purple Box stating "Any other request for investigational product, or medicinal product not yet available in your country'
3. Click "Access to the Form"
4. A pop-up box will open and say that "You are about to leave Sanofi.com." Click "Proceed"
5. On the Sanofi Compassionate Use/ MAP website, complete all the required information Compassionate Use/Managed Access Program (smartsheet.com)
6. Under Product Request, Drug/Product, select "Other" and type "Glucantime"
7. Sanofi will review the information and reach out to collect additional information including IND paperwork
8. Forms/Documents Required by Sanofi to generate Letter of Authorization (LOA):
a. A copy of physician’s current medical license
b. Physician Agreement or Signed Cover Letter (attached), Compassionate Use Cover Letter: signed and dated (provided by Sanofi)
c. Managed Access Programs Request – Medical History Form (provided by Sanofi)
d. Results of lab and/or other tests, if applicable
e. Compassionate Use Request Form (provided by Sanofi)
Once the above have been sent, Sanofi will generate LOA to send to FDA
9. Other forms required by Sanofi:
a. A copy of the FDA’s acknowledgement correspondence with the IND #
b. A signed copy of your site’s IRB letter of approval for this Compassionate Use request
c. Patient informed consent form from your institution
d. Letter of Request for FDA and Customs clearance of the shipment with IND number on it from physician. (Required to facilitate shipment through customs)
Example: Dr. ____ I am requesting ____ vials of Glucantime for the patient who is currently under my care for cutaneous leishmaniasis with ______ (species), which has been resistant to the FDA-approved treatment of liposomal amphotericin B. The FDA has notified me that they have assigned this drug the IND # ___________ for Extended use/Compassionate use for this patient. Please see attached acknowledgement letter from the FDA for the patient to have the medication to treat _______ (species).
Additional Helpful Information
Manufacturer of the Glucantime is Haupt Pharma Livron S.A.S, 1 Rue Cornte de Sinard 26250 Livron Sur Drome, France. Sanofi is the distributor of the drug product.
Registered in: France, Spain, Algeria, Morocco, Tunisia, Armenia, Georgia, Iran, Pakistan, Syria, Turkmenistan, Bolivia, Brazil, Colombia, Costa Rica, Ecuador, El Salvador, Guatemala, Nicaragua, Panama and Peru.