Exciting News: US FDA Grants Priority Review Designation to Zealand Pharma’s Dasiglucagon for Congenital Hyperinsulinism Treatment

Major Breakthrough: Zealand Pharma’s Dasiglucagon Gains Priority Review by US FDA for Innovative Treatment of Congenital Hyperinsulinism

Copenhagen, Denmark, August 30, 2023 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a pioneering biotechnology company focused on revolutionizing peptide-based medicines, is thrilled to unveil a significant milestone. The US FDA has just granted priority review designation to Zealand Pharma’s groundbreaking drug, Dasiglucagon. This innovative therapy aims to transform the lives of pediatric patients, aged 7 days and above, suffering from congenital hyperinsulinism (CHI). The eagerly anticipated Prescription Drug User Fee Act (PDUFA) date has been set for December 30, 2023, and the excitement is palpable.

In an unprecedented approach, the regulatory review process for Dasiglucagon will unfold in two distinct parts within the same New Drug Application (NDA). Part 1 is geared toward dosing over a span of up to 3 weeks, while Part 2 focuses on its use beyond this initial period. Part 2’s PDUFA date will be determined post the submission of additional analyses requested by the US FDA, expected to be completed by year-end. Zealand Pharma remains fully committed to optimizing this transformative treatment for CHI and is geared up for the collaborative journey ahead.

Dr. Linda Wu, Chief Development Officer of Zealand Pharma, expressed, “This remarkable priority review status from the US FDA underscores the immense potential of Dasiglucagon in revolutionizing the prevention and treatment of hypoglycemia in children afflicted with CHI. We stand united with the global medical community to address this critical unmet need.”

Three Phase 3 clinical trials

Zealand Pharma’s ground-breaking approach to treating CHI rests on a solid foundation of robust clinical trials. The comprehensive Phase 3 program involved two pivotal trials and an ongoing long-term extension study, collectively yielding invaluable insights and exceptional results.

The first trial (NCT04172441) primarily assessed Dasiglucagon’s efficacy and safety in a hospital setting with neonates and infants aged 7 days to 12 months. The trial’s remarkable findings demonstrated a 55% reduction in the need for glucose intravenous infusion when Dasiglucagon was administered. The second trial (NCT03777176), focusing on children aged 3 months to 12 years, showcased how Dasiglucagon, when added to standard care therapies and monitored using continuous glucose monitoring (CGM), led to a reduction in hypoglycemia time by around 50% and hypoglycemic events by approximately 40%. These outcomes mark a monumental leap forward in treating CHI.

David Kendall, MD, Chief Medical Officer of Zealand Pharma, emphasized, “This priority review timeline reinforces our commitment to advancing Dasiglucagon as a transformative solution for infants and children battling CHI. The dual-phase review underscores our dedication to delivering innovative treatments swiftly to patients in dire need.”

Zealand Pharma’s pursuit of groundbreaking solutions continues to shape a future where innovative therapies redefine medical possibilities.

About congenital hyperinsulinism

Unlocking Hope for the Most Vulnerable: Pioneering Advances in Congenital Hyperinsulinism Treatment

Congenital hyperinsulinism (CHI), a profoundly rare genetic disorder, casts a shadow of uncertainty over the lives of infants and children. In this intricate condition, the body’s pancreatic beta cells misfire, releasing an excess of insulin. This surge triggers frequent, severe bouts of hypoglycemia, a dangerous drop in blood sugar levels. These recurring episodes, if left unchecked, can pave the path to seizures, brain impairment, and even fatality. CHI’s prevalence is a staggering 1 in 50,000 children, translating to a heart-wrenching 180-300 newborns grappling with its challenges annually in the US and Europe.

The impact on these young lives is profound. The complexities of CHI demand continuous glucose infusions, leading to lengthy hospital stays and disrupted daily routines. Both patients and their families find their lives held hostage by this relentless condition. Presently, the lone approved treatment, diazoxide, poses its own risks—fluid retention, hypertension, and acute heart failure—adding further burdens to patients’ lives. While glucagon and octreotide offer hope, they remain unapproved remedies.

Surprisingly, over 50% of CHI patients do not respond adequately to existing medical interventions, spotlighting a glaring unmet need for more effective treatments. In the face of these challenges, a beacon of hope emerges with Zealand Pharma’s breakthrough treatment for CHI. Through pioneering research and unwavering commitment, Zealand Pharma strives to rewrite the narrative for these young fighters, ushering in a new era of care and resilience.

About dasiglucagon

A new dawn is breaking for the challenging realm of congenital hyperinsulinism (CHI), and Zealand Pharma is at the forefront of this transformative journey. With unwavering dedication, Zealand Pharma is probing the capabilities of dasiglucagon, a potent glucagon receptor agonist, as a potential game-changer in CHI treatment. By coaxing the liver to release its stored sugar reserves into the bloodstream, dasiglucagon holds the promise of bringing much-needed relief to those grappling with this relentless genetic disorder.

But Zealand Pharma’s innovation doesn’t stop there. Envisioning a more seamless way to administer dasiglucagon, the company has embarked on the development of a subcutaneous continuous infusion system. This wearable pump system could potentially offer a lifeline to those impacted by CHI, transforming the way treatment is delivered and experienced.

The journey is one of collaboration and commitment. Zealand Pharma has joined forces with DEKA Research & Development Corporation and affiliates to craft this cutting-edge subcutaneous infusion pump system. Together, they strive to not only provide treatment but to enhance the quality of life for patients and their families.

Dasiglucagon’s impact isn’t confined to CHI alone. In a significant stride forward, the US FDA granted approval for dasiglucagon injection under the name Zegalogue® in 2021. This breakthrough marked a pivotal moment for the treatment of severe hypoglycemia in adults and children with diabetes aged 6 years and older.

Emboldened by this milestone, Zealand Pharma embarked on a new endeavor, submitting a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in June 2023. This step heralds the potential expansion of dasiglucagon’s reach, extending its benefits to adults, adolescents, and children aged 6 years and over with diabetes.

Recognizing the power of collaboration, Zealand Pharma forged a global license and development agreement with Novo Nordisk in September 2022. Together, they are forging ahead with the commercialization of dasiglucagon injection, striving to bring relief to individuals facing severe hypoglycemia in the diabetes community.

Zegalogue® isn’t just a trademark; it symbolizes a new era of hope and innovation, a beacon of possibility lighting the way for a brighter future in diabetes care.

About Zealand Pharma

Venture into the realm of innovation with Zealand Pharma A/S, a biotechnology trailblazer poised at the crossroads of discovery and development. With a profound focus on harnessing the potential of peptide-based medicines, Zealand is rewriting the narrative of healthcare possibilities.

Zealand’s legacy of innovation is woven with threads of perseverance and breakthroughs. Over a decade of relentless dedication has borne fruit, as more than 10 pioneering drug candidates, conceived within Zealand’s walls, have embarked on transformative journeys through clinical development. Among these, two have successfully paved their way to the market, marking triumphs in healthcare innovation. An impressive trio of candidates stand on the brink of realization, brimming with potential to redefine medical landscapes.

Zealand’s success story is intertwined with a web of collaborations that span the pharmaceutical universe. Development partnerships with esteemed pharma counterparts form the backbone of Zealand’s vision. Beyond the confines of laboratories, Zealand has forged commercial partnerships that have propelled its remarkable products onto the global stage.

The tale of Zealand Pharma began in 1998, with roots firmly planted in the vibrant heart of Copenhagen, Denmark. This bustling hub of creativity and innovation serves as Zealand’s headquarters, where ideas take shape and dreams are woven into reality. But the story doesn’t stop there; Zealand’s reach extends across oceans, with a compelling presence in the U.S., nestled within the dynamic city of Boston.

Zealand Pharma A/S is not just a company; it’s a journey, an odyssey fueled by passion, dedication, and a relentless pursuit of innovation. Step into the world of Zealand, where the future of medicine is being shaped, one peptide at a time.

Forward looking statements

Step into the realm of possibilities, where Zealand Pharma (Nasdaq: ZEAL) unveils its vision with a tapestry of forward-looking statements. These words paint a vivid picture of our aspirations for the future of pharmaceutical innovation, research, development, and commercialization. Through this lens, we invite you to explore the horizons of potential.

The canvas of our intentions is adorned with phrases like “anticipate,” “forecast,” and “potential.” These words are not mere text; they’re windows to the future we envision. As we navigate the intricate path of pharmaceutical progress, we’re guided by these aspirations that light our way.

Amid the crescendo of optimism, a note of caution resounds. We urge you not to place undue reliance on these forward-looking statements. While they illuminate the possibilities, they are not certainties. The world of pharmaceuticals is a complex tapestry woven with threads of risks and uncertainties. Our words are an exploration, a projection, but not a guarantee.

Peering into the future, we acknowledge the unforeseen challenges that may arise. Unexpected costs, delays, safety concerns — these are the currents that occasionally alter our course. The journey of clinical trials may lead us to unforeseen insights, prompting us to recalibrate our expectations. As we safeguard our intellectual property, we’re prepared for the potential twists and turns that the world of regulatory approvals may bring.

As the tale of Zealand Pharma unfolds, we want to remind you that our forward-looking statements are not set in stone. They evolve with time, reflecting the dynamic landscape we navigate. Our commitment is steadfast — to update you, to share our journey, and to align our vision with the realities we face.

As we venture into the unknown, let these words echo as a reminder: our journey is not just about pharmaceuticals; it’s about pushing boundaries, fostering innovation, and rewriting the future of healthcare. Zealand Pharma’s vision remains ever-evolving, a testament to our commitment to shaping a better tomorrow.

Leave a Comment