Posted from: Tuesday, January 16, 2018 - 12:33 PM - Present

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.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

Last Updated Wednesday, July 18, 2018 - 05:29 AM.