Transcon PTH (Now known as YORVIPATH) has recieved FDA Approval
August 10, 2024
At the Hypoparathyroidism Association we are just thrilled for the approval of Yorvipath (previously know as Transcon PTH). We have watched so many patients go through the clinical trials and watched their lives change dramatically with Yorvipath.
Yorvipath
On August 12th 2024, Ascendis Pharma announced that the FDA had approved YORVIPATH (palopegteriparatide), their new parathyroid hormone, as a treatment for chronic hypoparathyroidism in adults in the United States.
You can read their press release Official Press Release
What is Yorvipath?
Yorvipath is a prodrug of parathyroid hormone (PTH 1-34) administered by injection once daily. Previously known as Transcon PTH in the USA it has shown very good results in Phase III trials with patients able to come off calcium and Calcitriol and improve kidney function and quality of life. PUBMED ARTICLE
If all goes well, when could we get Yorvipath?
"Ascendis is completing manufacturing of commericial product for the U.S. market and anticipates initial supply will be available in the first quarter of 2025. In addition, Ascendis plans to request FDA approval to commercialize existing manufactured product, which, if approved, could be introdued in the U.S. in the fourth quarter of 2024."
What to do while waiting?
Celebrate!!!! We have an official approved drug to help our community.
Change your language from Transcon PTH to Yorvipath. This will be important when it comes to market.
In the meantime you may be able to access Yorvipath via the Transcon EAP program. Read more about the EAP program here Ascendis EAP Your doctor can call 1-844-442-7236 or submit a form at https://ascendispharmamedinfo.us to find you an EAP provider.
Learn all you can about Yorvipath so you can have a discussion with your doctor about if it's right for you. Visit the Ascendis website for more information. Visit the Ascendis website for more information. Ascendis Pharma Yorvipath Full Prescribing Info
Also prepare yourself for getting it approved through your insurance. It is always in your best interest to understand your insurance, understand what a prior authorization is and how to work through it with your insurance company. Also have resources like Patients Rising's phone number at the ready so they can help with the process as well Patient Helpline
Why doesn't a medication become prescribable as soon as it is approved by the FDA?
Bringing a drug to market is a very complicated process and there are many things that have to take place before your doctor can prescribe it (that doesn't mean you can't talk to them about it before then) and a pharmacy can dispense it. There are also many things that need to take place before your insurance company will even know the drug exists.
***No one will know the price until these things take place*** Here is a statement from Ascendis "At launch, Ascendis plans to offer a suite of patient services for YORVIPATH through its U.S. Ascendis Signature Access Program (A.S.A.P.), including support navigating the treatment journey and financial assistance programs for eligible patients."
Here are some resources about the process
How Drugs are Developed and Approved
What to know about your Drug Formulary List
What is a PBM? (Pharmacy Benefit Manager)
5 Things To Know About Pharmacy Benefit Managers
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