Astellas Pharma US, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug and pediatric exclusivity to CRESEMBA® (isavuconazonium sulfate) for the treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM) in pediatric patients.
| Designation follows December 2023 FDA approval for the treatment of these serious, potentially life-threatening fungal infections in children CRESEMBA receives seven years and six months of US market exclusivity for these pediatric indications NORTHBROOK, Ill., March 11, 2024 /PRNewswire/ -- Astellas Pharma US, Inc. (TSE: 4503, President: Mark Reisenauer, “Astellas”) announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug and pediatric exclusivity to CRESEMBA® (isavuconazonium sulfate) for the treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM) in pediatric patients. On December 8, 2023, CRESEMBA for injection was approved for pediatric patients 1 year of age and older and capsules for pediatric patients 6 years of age and older who weigh 16 kilograms (kg) and greater.
The FDA grants orphan drug exclusivity to orphan drugs that receive FDA marketing approval. As the first company to obtain FDA approval for the treatment of IA and IM in patients as young as one for a triazole antifungal, Astellas has received orphan drug exclusivity, which provides seven years of exclusive marketing rights for CRESEMBA in those indications beginning from the date of approval of the supplemental New Drug Application on Dec. 8, 2023. Pediatric exclusivity extends that period by another six months. The FDA previously granted orphan drug exclusivity for CRESEMBA in 2015 for the treatment of IA and IM in adults. Laura Kovanda, PhD, Executive Director, Asset Lead, BioPharma Development, Astellas CRESEMBA is the only azole antifungal therapy FDA approved for the treatment of IA and IM in patients as young as one. About Invasive Aspergillosis and Invasive Mucormycosis About CRESEMBA® (isavuconazonium sulfate)
Specimens for fungal culture and other relevant laboratory studies (including histopathology) to isolate and identify causative organism(s) should be obtained prior to initiating antifungal therapy. Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly. Important Safety Information for CRESEMBA (isavuconazonium sulfate) Contraindications
Warnings and Precautions Hepatic Adverse Drug Reactions (e.g., elevations in ALT, AST, alkaline phosphatase, total bilirubin) have been reported in clinical trials and were generally reversible and did not require discontinuation of CRESEMBA. Cases of severe hepatic adverse drug reactions including hepatitis, cholestasis or hepatic failure including death have been reported in patients with serious underlying medical conditions (e.g., hematologic malignancy) during treatment with azole antifungal agents, including CRESEMBA. Evaluate liver tests at the start and during therapy. Monitor patients who develop liver abnormalities during CRESEMBA therapy for severe hepatic injury. Discontinue if clinical signs and symptoms consistent with liver disease develop that may be attributable to CRESEMBA. Infusion-Related Reactions including hypotension, dyspnea, chills, dizziness, paresthesia, and hypoesthesia were reported during intravenous administration of CRESEMBA. Discontinue the infusion if these reactions occur. Hypersensitivity Reactions: Anaphylactic reactions, with fatal outcome, have been reported during treatment with CRESEMBA. Serious skin reactions, such as Stevens Johnson syndrome, have been reported during treatment with other azole antifungal agents. Discontinue CRESEMBA if anaphylactic or serious skin reactions occur, and initiate supportive treatment as needed. Embryo-Fetal Toxicity: During pregnancy, CRESEMBA may cause fetal harm when administered, and CRESEMBA should only be used if the potential benefit to the patient outweighs the risk to the fetus. Women who become pregnant while receiving CRESEMBA are encouraged to contact their physician. Drug Interactions: Coadministration of CRESEMBA with strong CYP3A4 inhibitors such as ketoconazole or high-dose ritonavir and strong CYP3A4 inducers such as rifampin, carbamazepine, St. John’s Wort, or long acting barbiturates is contraindicated. Drug Particulates: Following dilution, CRESEMBA intravenous formulation may form precipitate from the insoluble isavuconazole. Administer CRESEMBA through an in-line filter. Adverse Reactions In adult patients, the most frequently reported adverse reactions among CRESEMBA-treated patients were nausea (26%), vomiting (25%), diarrhea (22%), headache (17%), elevated liver chemistry tests (16%), hypokalemia (14%), constipation (13%), dyspnea (12%), cough (12%), peripheral edema (11%), and back pain (10%). In adult patients, the adverse reactions which most often led to permanent discontinuation of CRESEMBA therapy during the clinical trials were confusional state (0.7%), acute renal failure (0.7%), increased blood bilirubin (0.5%), convulsion (0.5%), dyspnea (0.5%), epilepsy (0.5%), respiratory failure (0.5%), and vomiting (0.5%). In pediatric patients, the most frequently reported adverse reactions were diarrhea (26%), abdominal pain (23%), vomiting (21%), elevated liver chemistry tests (18%), rash (14%), nausea (13%), pruritus (13%), and headache (12%). In general, adverse reactions in pediatric patients (including serious adverse reactions and adverse reactions leading to permanent discontinuation of CRESEMBA) were similar to those reported in adults. For Full Prescribing Information, please visit here. About Astellas Pharma US About Astellas Cautionary Notes 1 Thornton CR. Detection of invasive aspergillosis. Adv Appl Microbiol. 2010;70:187-216. doi: 10.1016/S0065-2164(10)70006-X. Epub 2010 Mar 6. PMID: 20359458.
SOURCE Astellas Pharma US, Inc. | ||
Company Codes: Tokyo:4503, OTC-PINK:ALPMY |
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