Macrilen Approved as Diagnostic Agent for AGHD
December 20, 2017 – The U.S. FDA has approved Macrilen™ (macimorelin), manufactured by Aeterna Zentaris, as a diagnostic agent for use in evaluating patients for adult growth hormone deficiency (AGHD).
Macrilen, a ghrelin agonist, works by triggering growth hormone production from the pituitary gland. Doctors can then measure the amount of growth hormone found in the blood, which is done four times in the course of ninety minutes after Macrilen has been administered. Macrilen is less invasive than the previous standard for diagnosis of AGHD, as it requires only that patients take a single dose of oral solution and have four blood draws. The previous standard, the insulin tolerance test (ITT), requires an intravenous line and multiple blood draws over the course of several hours. For some patients, ITT is potentially risky, as it requires hypoglycemia be induced to achieve accurate results.
Recommended dosing with Macrilen is based on weight, at 0.5mg/kg. Patients should fast for a minimum of eight hours before taking Macrilen. The drug must be prepared and administered by a healthcare professional, and must be used within 30 minutes of preparation. It will be available in pouches containing 60mg of Macrilen granules for reconstitution. Patients may need to temporarily discontinue certain drugs or supplements, including strong CYP3A4 inducers and drugs that affect growth hormone secretion, to obtain accurate test results with Macrilen.
Launch is planned for the first quarter of 2018. Pricing information is not yet available.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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