OK, this is not fake news….. the press release below details a new, exclusive-distribution arrangement for an oral therapy, Lysodren, with an indication for inoperable, functional or non-functional adrenocortical carcinoma.
Is this big news….. Not really.
Is this odd news…. Yes it is.
Because Lysodren (mitotane) was first approved in 1970….. yes, 50 years ago.
Mitotane is on the list of ‘Off-Patent, Off-Exclusivity Drugs without an Approved Generic’ as published in the Orange Book. Why it doesn’t have an approved generic is anybody’s guess….. there are lots of old brand drugs with no generics on that list waiting for someone to come along and relaunch an old cheap drug at 100+++ times the old price. Currently, Lysodren runs only $500+ per month of therapy.
The new FDA Label includes a black box warning for adrenal crisis…. which may be the primary reason that this drug is going limited distribution.
It appears that there is renewed interest in this old therapy. Over the decades it has been used routinely by veterinarians to treat carcinoma in animals.
AllianceRx Walgreens Prime named exclusive distributor for HRA Pharma Rare Diseases
FDA-approved prescription drugs Lysodren® and Metopirone® in the United States
Oct 29, 2020 — ORLANDO, Fla. and MORRISTOWN, N.J. and CHATILLON, France, PRNewswire. HRA Pharma Rare Diseases has named AllianceRx Walgreens Prime as the exclusive specialty pharmacy and clinical support provider for two of its rare disease drugs, Lysodren and Metopirone.
Lysodren (mitotane) is the only FDA-approved drug to treat inoperable, functional or non-functional adrenocortical carcinoma, a rare cancer of the adrenal glands. Metopirone (metyrapone) is used as a diagnostic test for adrenocorticotropic hormone (ACTH) insufficiency and in the diagnosis of ACTH-dependent Cushing’s syndrome. ACTH is a hormone produced in the pituitary gland in the brain.
“We are very excited to be the exclusive pharmacy to dispense these medicines,” says Tracey James, senior vice president of pharmacy services at AllianceRx Walgreens Prime. “HRA Pharma Rare Diseases recognizes our ability to clinically support patients throughout their treatment journey and link them to financial resources so they can obtain these life-changing medicines. HRA Pharma Rare Diseases and AllianceRx Walgreens Prime share the same goal of providing the best possible outcomes for these patients.”
Evelina Paberze, chief operating officer of HRA Pharma Rare Diseases, says, “At HRA Pharma Rare Diseases, we are dedicated to giving our patients improved access to essential treatments. The decision to make AllianceRx Walgreens Prime our exclusive specialty pharmacy and clinical support provider means our rare disease patients in the U.S. will get improved access to Lysodren and Metopirone.”
David Wright, chief executive officer of HRA Pharma, says, “At HRA Pharma, we constantly strive to provide accessible and affordable solutions to our patients. I believe making AllianceRx Walgreens Prime the exclusive pharmacy of our rare diseases affiliate is a step in the right direction to achieving this goal.”
For full prescribing information on the drugs listed above, including the black box warning for Lysodren®, visit dailymed.nlm.nih.gov.