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Zealand Pharma (ZEAL)

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  1. moi!! 23 maart 2021
    Zealand Pharma Announces FDA Approval of Zegalogue® (dasiglucagon) injection, for the Treatment of Severe Hypoglycemia in People with Diabetes
    March 22, 2021 17:50 ET | Source: Zealand Pharma




    Company announcement – No. 16 / 2021

    Zealand Pharma Announces FDA Approval of Zegalogue® (dasiglucagon) injection, for the Treatment of Severe Hypoglycemia in People with Diabetes

    Zegalogue will be available in both an auto injector and a prefilled syringe for the treatment of severe hypoglycemia in patients with diabetes age 6 or older
    Approval based on results from three pivotal trials in adults and children with diabetes, showing median time to blood glucose recovery from severe hypoglycemia of 10 minutes following injection of 0.6 mg/0.6 mL Zegalogue
    Company to host conference call Tuesday, March 23 at 1:00PM CET (8:00AM ET)
    Copenhagen, DK and Boston, MA, U.S. March 22, 2021 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078,) a biotechnology company aspiring to deliver innovation with novel peptide therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has approved Zegalogue® (dasiglucagon) injection for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above.

    “This approval will help enable appropriate children and adults with diabetes to be able to address sudden and severe hypoglycemia, which can quickly progress from a mild event to an emergency,” said Dr. Jeremy Pettus, MD, Assistant Professor of Medicine at the University of California San Diego. “The magnitude and consistency of effect seen in the Phase 3 pivotal studies is clinically meaningful as minutes matter in severe hypoglycemia. Zegalogue provided resolution of severe hypoglycemia following administration, with a median time to blood glucose recovery of 10 minutes across these clinical studies.”

    Severe hypoglycemia is an acute, life-threatening condition resulting from a critical drop in blood glucose levels associated primarily with insulin therapy and is one of the most feared complications of diabetes treatment1. Children with diabetes on insulin are particularly affected, with 7 out 100 children up to the age of 18 reporting severe hypoglycemia in the previous 6 months2. While patients have the ability to monitor and adjust their blood glucose levels to remain in proper glycemic control, it’s not always possible to prevent a severe hypoglycemic event.

    “The U.S. FDA approval of Zegalogue is an exciting achievement for both patients and Zealand,” said Emmanuel Dulac, President and CEO of Zealand Pharma. “We would like to thank the trial participants, their families and caregivers, the investigators and their staff, and our employees who made the Zegalogue clinical studies and this resulting approval possible. We are committed to helping people with diabetes manage the potential consequences of their disease and look forward to making Zegalogue available in the U.S. in June. Field sales, market access and medical teams, along with comprehensive patient support services, are in place to maximize awareness to healthcare providers and preparedness to patients affected by severe hypoglycemia.”

    The FDA approval was based on efficacy results from three randomized, double-blind, placebo-controlled multicenter Phase 3 studies of Zegalogue in children aged 6 to 17 and in adults with type 1 diabetes. The primary efficacy endpoint for all three studies was time to plasma glucose recovery (treatment success), defined as an increase in blood glucose of =20 mg/dL from time of administration, without additional intervention within 45 minutes. The primary endpoint was successfully achieved across the adult and pediatric studies with a significantly faster median time to blood glucose recovery of only 10 minutes following Zegalogue administration compared to 30-45 minutes placebo. In the main Phase 3 adult trial 99% of patients recovered within 15 minutes.

    In these studies, the most common adverse events reported (=2%) were nausea, vomiting, headache, diarrhea, and injection site pain in adults; and nausea, vomiting, headache, and injection site pain in pediatrics.
  2. forum rang 4 Ron Kerstens 23 maart 2021 12:25
    quote:

    KVE83 schreef op 23 maart 2021 07:12:


    Gisteren op de Nasdaq nabeurs gesloten op 224 DKK omgerekend. Het kan denk wel wel weer naar de 300DK gaan. Het heeft een markt van 1,5 miljard. Alleen weet ik niet hoeveel andere bedrijven hetzelfde medicijn maken.


    Er zijn bij mijn weten twee goedkeuringen verleend in 2019, Eli Lilly (intranasale glucagon BAQSIMI) en Xeris Phamarma (Gvoke). Beide kosten ca 300 dollar per flesje.

    Maar toch een geruststelling dat de goedkeuring erdoorheen is en ze het op de markt kunnen brengen. Dasiglucagon zit nog in 3 andere lopende programma's dus dit is een goede start.
  3. Cannondale 23 maart 2021 13:04
    quote:

    Ron Kerstens schreef op 23 maart 2021 12:25:


    [...]

    Er zijn bij mijn weten twee goedkeuringen verleend in 2019, Eli Lilly (intranasale glucagon BAQSIMI) en Xeris Phamarma (Gvoke). Beide kosten ca 300 dollar per flesje.

    Maar toch een geruststelling dat de goedkeuring erdoorheen is en ze het op de markt kunnen brengen. Dasiglucagon zit nog in 3 andere lopende programma's dus dit is een goede start.


    Verschillende programma's in phase II en III ... net dat maakt Zealand Pharma zo aantrekkelijk. Het eerste product nu op de markt is inderdaad een geweldige opsteker. En zoals al aangegeven .. ze hebben recent cash opgehaald om de programma's verder te financieren. The only way is up ...
190 Posts
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