something old, something new – a brief history of Acthar

As most of you are aware Acthar has been approved by the FDA for treatment of Polymyositis and Dermatomyositis. Acthar is a self-injected treatment which you do at home. There is a lot of information about how to use the drug, including step by step instruction videos on the official drug site. Click here.

 

Thanks Wikipedia, Adrenocorticotropic hormone (ACTH), also known as corticotropin, is a polypeptide tropic hormone produced and secreted by the anterior pituitary gland. H.P. Acthar Gel is a highly purified preparation of ACTH that is designed to provide extended release of it following injection. Unlike prednisone, it is not a steroid. It works by stimulating the outer layer of cells of the adrenal gland, promoting the production of steroid hormones (cortisol, corticosterone, aldosterone) that reduce inflammation.

 

Since the drug has only been used on a small myositis population its side-effects are not fully documented yet. They are considered similar but not as severe to steroids such as prednisone, i.e. round face, mode swings, thin skin, unable to sleep etc. I hear it can also cause a mild taste disturbance. From the official drug site, “Acthar should not be used in patients with a skin condition called scleroderma, bone density loss (osteoporosis), infection throughout the body, eye infection called ocular herpes simplex, recent surgery, history of or a current stomach ulcer, heart problems, high blood pressure, or allergy to pig-derived proteins.”

 

Acthar is not a new drug – it was first synthesized way back in the 1940’s from pig pituitary glands by Armour meatpacking company as a way to generate money for unwanted pig parts. Who knew it would go on to become the most expensive part of the pig! Acthar was approved for treatment for Dermatomyositis and Polymyositis in 1952.  Sometimes referred to being “grandfathered-in” for these treatments, you can be rest assured that the drug continues to meet FDA standards. You can read about that process, click here.

 

Eventually the drug was owned by Aventis, which nearly discontinued production in the mid-1990’s due to poor sales. Questcor acquired the rights to Acthar Gel in 2001. Although the patent for the drug has long since expired, synthesizing the drug has proved difficult which only Questcor has been able to commercially achieve.

 

A lot has been written about written about Questcor’s pricing of Acthar. Click here. Last year Questcor bought the US rights to Synacthen, a similar drug, from Novartis, which has kicked off an anti-trust lawsuit.  Some health insurance companies, such as Aetna, no longer approve Acthar for treatment. That said, I will add that Questcor is a big supporter of the TMA and has provided $250M of the drug at no cost.

 

On balance I am happy that there is another drug on the market to combat Polymyositis and Dermatomyositis although I wish it was cheaper and thus more accessible to the myositis community.

 

I first became aware of Acthar when Dr. Todd Levine spoke about it at the 2012 Annual Myositis Patient Conference. He treated five Polymyositis/Dermatomyositis patients who experienced a worsening of the disease or unable to tolerate the side-effects of other treatments. Although the webcast is no longer available, you can read about the case studies, click here.  The TMA also had a Live Discussion with Dr. Levine about the drug last year, please click here. A national registry was started by him to understand its use in the treatment of myositis.

 

The reason I write about Acthar is that after seven years I am having my first flare up of Dermatomyositis. Given how difficult my disease was to treat in the past, my rheumatologist is considering me for Acthar. However my insurance company has denied me using the drug. This is now being appealed. If I do get to use the drug I will blog about my experiences.

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