An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. *
FDA Approves SKYTROFA® for the Once-Weekly Treatment of Adults with GHD
On July 28, Ascendis Pharma A/S announced that the U.S. Food & Drug Administration (FDA) has approved SKYTROFA® (lonapegsomatropin-tcgd; developed as TransCon hGH) for the replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD), a rare disorder resulting from decreased or total loss of growth hormone production.
Lonapegsomatropin (approved by the FDA in 2021 for the treatment of pediatric GHD) is a prodrug of somatropin (human growth hormone, or hGH) administered once weekly, providing sustained release of active, unmodified somatropin.
The FDA’s approval of SKYTROFA for adult GHD was based on results from foresiGHt, a Phase 3 randomized, parallel-arm, placebo-controlled (double-blind) and active-controlled (open-label) clinical trial that compared the efficacy and safety of weekly TransCon hGH with weekly placebo and daily somatropin in adults with GHD.
“The abnormal body composition, dyslipidemia, and insulin resistance that are the hallmarks of adult GHD predispose affected individuals to serious medical complications such as metabolic syndrome, increased cardiovascular risk, and impaired quality of life – including cognitive dysfunction, depression, anxiety, sleep disturbance, and reduced physical and mental drive. Despite this, adherence to daily somatropin injections that have been the standard of care for more than 25 years remains a problem,” said Kevin Yuen, MD, Barrow Neurological Institute, University of Arizona College of Medicine and Creighton University School of Medicine in Phoenix, Ariz. “It is no surprise that patients are looking for a less burdensome treatment regimen, and a new treatment option such as SKYTROFA, with once-weekly injection and its unique release of unmodified somatropin, is expected to help improve both real-world adherence and overall outcomes.”
“Our market research shows SKYTROFA is the treatment of choice for pediatric GHD among patients and physicians, and we are pleased to expand its availability in the United States for the treatment of adults initiating therapy or switching from another growth hormone therapy,” said Jan Mikkelsen, president and chief executive officer at Ascendis Pharma. “This important milestone is the first of many planned label expansions supporting our goal to become the leading endocrinology rare disease company.”
Oliva Therapeutics Announces Availability of Thyquidity®
On July 23, Oliva Therapeutics, a US-based healthcare company focused on product commercialization, sales, marketing, distribution, and promotion, announced today the relaunch and immediate availability of Thyquidity® (Levothyroxine Sodium Oral Solution).
“We are grateful for the patience shown by the existing Thyquidity® patient base as we worked tirelessly with our manufacturing partner to deliver new supply,” said Michael Turnamian, COO of Oliva Therapeutics. “Thyquidity® offers a flexible option with several years of proven reliability.”
In partnership with Jerome Stevens Pharmaceuticals, Inc., a US-based prescription pharmaceutical manufacturer and packager, the launch of Thyquidity® represents the first branded product launch for Oliva Therapeutics and expands upon a joint endocrine-focused portfolio and pipeline.
“The relaunch of Thyquidity® represents the next step in our family vision as a leader in the thyroid therapeutic class,” said Daniel Akeson, Director of Jerome Stevens Pharmaceuticals and CEO of Oliva Therapeutics, LLC. “We look forward to ensuring reliable supply and executing our near-term endocrine pipeline.”
Oliva Therapeutics has established a monitored email address for customers and patients to support product locating and ordering, [email protected], as well as a regularly updated information page at thyquidity.com.
*Inclusion in Pharma Fridays does not suggest an endorsement by Endocrine News or the Endocrine Society.
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