CRESEMBA is already approved by the FDA for the treatment of IA and IM in adults. If approved for pediatric use, it may offer children significant advances in treatment or may provide a treatment where no adequate therapy exists. IA and IM are a major cause of morbidity and death among immunocompromised and hospitalized pediatric patients.1
"While rare in the general population, invasive aspergillosis or invasive mucormycosis can be incredibly dangerous for immunocompromised children, including those faced with blood and other cancers, and there are very limited treatment options," said Tadaaki Taniguchi, MD, PhD, chief medical officer, Astellas. "The collective efforts by our research and development teams, which have led to the successful sNDA acceptance for CRESEMBA by the FDA, reflect our ongoing commitment to addressing vulnerable populations with high unmet medical needs."
"Since its approval over eight years ago, CRESEMBA has been helping adult patients and their physicians fight certain life-threatening fungal infections when they are often critically ill with other diseases," said Lynn Fenicchia, senior vice president and Head of U.S. Medical Specialties Business Unit, Astellas. "This sNDA acceptance by the FDA brings Astellas one step closer to helping pediatric patients by potentially having a new treatment option available for IA and IM for a younger patient population, if approved."
The sNDA is based on results from a Phase 2 open-label, non-comparative, multicenter study (NCT03816176), evaluating the safety, efficacy and pharmacokinetics of CRESEMBA for the treatment of IA or IM in pediatric patients aged one to 17 years old. Detailed results will be presented at a future medical meeting.
Invasive aspergillosis can be a life-threatening fungal infection that is seen predominantly in immunocompromised patients, such as patients with leukemia.2Invasive mucormycosis is a rare and often life-threatening fungal infection, for which clinical and epidemiological understanding is lacking.3 Both IA and IM are known for high morbidity and mortality.2,3
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.
Coadministration of strong CYP3A4 inhibitors, such as ketoconazole or high-dose ritonavir (400 mg every 12 hours), with CRESEMBA is contraindicated because strong CYP3A4 inhibitors can significantly increase the plasma concentration of isavuconazole
Coadministration of strong CYP3A4 inducers, such as rifampin, carbamazepine, St. John's wort, or long-acting barbiturates with CRESEMBA is contraindicated because strong CYP3A4 inducers can significantly decrease the plasma concentration of isavuconazole
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 Particulates: Following dilution, CRESEMBA intravenous formulation may form precipitate from the insoluble isavuconazole. Administer CRESEMBA through an in-line filter.
Astellas Pharma US, Inc. is a U.S. affiliate of Tokyo-based Astellas Pharma Inc., a pharmaceutical conducting business in more than 70 countries around the world. Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the U.S. and around the world. For more information on Astellas, please visit: https://www.astellas.com/us. You can also follow us on Twitter at @AstellasUS, Facebook at www.facebook.com/AstellasUS or LinkedIn at www.linkedin.com/company/astellas-pharma-us.
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients. For more information, please visit our website at https://www.astellas.com/en.
Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties.
The safety and efficacy of the agents discussed herein are under investigation and have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for uses being investigated. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.
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