Indications: Neurofibromatosis type 1 (NF1), Plexiform neurofibroma (PN)
Physical and Chemical Properties
Selumetinib sulfate is white to yellow crystalline powder. Its solubility is pH dependent, pH < 1.5, Selumetinib sulfate is soluble; pH 1.5 - 3, Selumetinib sulfate is soluble; pH > 3, Selumetinib sulfate is slightly soluble.
Availability
April 11, 2020,The U.S. Food and Drug Administration (FDA) recently approved AstraZeneca's targeted anticancer drug Koselugo (selumetinib sulfate ) for pediatric patients aged ≥2 years with neurofibromatosis type 1 (NF1), with the specific indications for the drug: for the treatment of symptomatic NF1-associated , inoperable plexiform neurofibromas.
June 22, 2021,AstraZeneca and Merck & Co recently jointly announced that its targeted anticancer drug Koselugo (selumetinib sulfate) has been conditionally approved by the European Commission (EC) for pediatric patients aged 3 years and older with neurofibromatosis type 1 (NF1) for the treatment of symptomatic , non-surgically resectable plexiform neurofibromas (PN).
On September 26, 2022, the Japan Pharmaceutical and Medical Devices Agency (PMDA) approved Koselugo (selumetinib sulfate) for neurofibromatosis type 1 (NF1).
On April 28, 2023, the National Food and Drug Administration (NFDA) approved AstraZeneca's Koselugo (selumetinib sulfate) hydroxysimertinib capsules for use in neurofibromatosis type I (NF1) with symptomatic, inoperable plexiform neurofibroma (PN) in patients 3 years of age and older. pediatric patients and patients with plexiform neurofibroma (PN).
As of the end of 2023, selumetinib sulfate has been approved for marketing in more than 55 countries worldwide.
Global sales.
USD 0.38 billion in 2020, USD 108 million in 2021, USD 208 million in 2022 and USD 331 million in 2023.
Compound Patents
WO2003077914, applicant ARRAY BIOPHARMA, filed 3/13/2003.