FDA Approves Alkindi Sprinkle
FDA Approves Alkindi Sprinkle (hydrocortisone oral granules) for Pediatric Adrenocortical Insufficiency
September 30, 2020 — Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that the US Food and Drug Administration (FDA) has approved Alkindi Sprinkle (hydrocortisone oral granules) as replacement therapy in pediatric patients with adrenocortical insufficiency (AI).
This approval is based on a positive review of data from the Company’s comprehensive development programme for Alkindi Sprinkle, including a study to demonstrate bioequivalence with the US reference product, as well as a safety evaluation and tolerability extension study in Europe, which provides valuable long-term exposure data in support of market access in the US.
Alkindi Sprinkle is a patented, oral, immediate-release formulation of hydrocortisone granules in capsules designed for children. Alkindi Sprinkle comes in dose strengths consistent with age-appropriate dosing in children. This therapeutic approach has the potential to help patients less than seventeen years of age suffering from diseases due to cortisol deficiency in the US.
Diurnal has partnered with Eton Pharmaceuticals for the commercialisation activities of Alkindi Sprinkle in the US, including pricing and reimbursement. Eton will initially use product from Diurnal’s European Alkindi® supply chain, with an option to establish its own supply chain in the US in the future. As previously announced, under the terms of the licensing agreement, Diurnal will receive a $2.5m cash milestone payment upon first commercial sale of Alkindi Sprinkle in the US following grant of Orphan Drug Status. The Company will also receive a tiered royalty on sales ranging from low double-digits to high teens and is due tiered sales-based milestone payments of up to $45 million in aggregate subject to annual sales thresholds. These payments are in addition to the upfront payment of $5.0m received by Diurnal upon signing the contract with Eton in March this year.
Martin Whitaker, CEO of Diurnal, commented:
“We are delighted to receive US FDA approval for Alkindi®, which builds on the previous approval and successful launch of Alkindi® in Europe and marks our first product to reach the market in the US. Alkindi® Sprinkle becomes the only licensed treatment specifically designed for use in children with adrenocortical insufficiency, where there is a significant unmet patient need. We look forward to the anticipated launch of Alkindi® Sprinkle by our partner, Eton Pharmaceuticals, in Q4 2020 as we continue to drive towards becoming a world-leading specialty endocrinology business.”
About Alkindi Sprinkle (hydrocortisone oral granules)
Alkindi Sprinkle is a patented, oral, immediate-release pediatric formulation of hydrocortisone granules in capsules. Alkindi Sprinkle comes in dose strengths consistent with age-appropriate dosing in children. This therapeutic approach has the potential to help young patients less than seventeen years of age suffering from diseases due to cortisol deficiency including pediatric AI and congenital adrenal hyperplasia (CAH) in the US. The European Commission has granted a pediatric use marketing authorisation (PUMA) for Alkindi as replacement therapy of AI in infants, children and adolescents (from birth to <18 years old) in Europe. Alkindi is also approved in Israel and Australia.
About Pediatric Adrenocortical Insufficiency
Pediatric AI, including the genetic condition CAH is a condition characterised by deficiency in cortisol, an essential hormone in regulating metabolism and the response to stress. The primary symptoms of AI are chronic fatigue and patients are at risk of adrenal crisis and death if they do not have adequate cortisol replacement. AI is either primary or secondary, with primary AI resulting from diseases intrinsic to the adrenal gland and secondary AI resulting from pituitary diseases where there is a failure of stimulation of the adrenal by the pituitary of the signalling hormone ACTH (adrenocorticotropic hormone).
About Diurnal Group plc
Founded in 2004, Diurnal is a UK-headquartered, European specialty pharma company developing high quality products for the global market for the life-long treatment of chronic endocrine conditions, including congenital adrenal hyperplasia and adrenal insufficiency. Its expertise and innovative research activities focus on circadian-based endocrinology to yield novel product candidates in the rare and chronic endocrine disease arena.
Source: Diurnal Group plc
Posted: September 2020
- Alkindi New Drug Application Submitted to US FDA – December 2, 2019
Alkindi Sprinkle (hydrocortisone) FDA Approval History
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