U.S. FDA Approves Supplemental New Drug Application (sNDA) f
NORTHBROOK, Ill., Jan. 8, 2020 /PRNewswire/ -- Astellas Pharma Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for MYCAMINE® (micafungin for injection) in support of the treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age.
With the approval, MYCAMINE is the first antifungal drug approved in the United States specifically for the treatment of invasive candidiasis for this patient population. Candidiasis in newborns is associated with 20 percent mortality and significant morbidity and mortality in infants.i MYCAMINE was approved for adults for Candida infections in 2005, and in 2013 for pediatric patients aged four months and older.
"Although rare, invasive candidiasis in newborns constitutes a unique pathogenesis unlike that demonstrated in older children and adults as marked by a higher incidence of organ involvement, especially in the central nervous system," said Laura Kovanda, Ph.D, Senior Director, Global Development Project Leader, Infectious Diseases and Oncology, Astellas. "We're pleased with this decision and the potential benefits MYCAMINE may offer to young infants and their families impacted by invasive candidiasis."
The safety of MYCAMINE was assessed in 168 pediatric patients younger than 4 months of age who received varying doses of MYCAMINE in nine clinical trials.
The approved dose for MYCAMINE in neonates and young infants less than four months is 4 mg/kg once daily.
About Invasive Candidiasis
Invasive candidiasis is a fungal infection caused by a yeast called Candida.ii Candidemia is a bloodstream infection with Candida and is the most common form of invasive candidiasis. Invasive candidiasis infections are often associated with high rates of morbidity and mortality, as well as increases in cost and length of hospital stay.
The Centers for Disease Control (CDC) estimate that approximately 25,000 news cases of candidemia occur nationwide each year. iii The CDC also estimates that candidemia occurs in 9 of every 100,000 persons per year.
MYCAMINE (micafungin for injection) is an echinocandin indicated for use in adult and pediatric patients. MYCAMINE inhibits an enzyme essential for fungal cell wall synthesis and is fungicidal (lethal) for Candida. MYCAMINE can be used concomitantly with a variety of other drugs, including the HIV protease inhibitor ritonavir and transplant medications cyclosporine and tacrolimus.iv
IMPORTANT SAFETY INFORMATION
MYCAMINE is contraindicated in persons with known hypersensitivity to micafungin sodium, any component of MYCAMINE, or other echinocandins.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: Anaphylaxis and anaphylactoid reactions (including shock) have been observed. Discontinue MYCAMINE and administer appropriate treatment.
Hematological Effects: Cases of acute intravascular hemolysis, hemolytic anemia and hemoglobinuria have been reported. Monitor rate of hemolysis and evaluate for the risk/benefit of continuing MYCAMINE therapy.
Hepatic Effects: Abnormalities in liver tests; isolated cases of hepatic impairment, hepatitis, and hepatic failure have been observed. Monitor hepatic function and evaluate for the risk/benefit of continuing MYCAMINE therapy.
Renal Effects: Elevations in BUN and creatinine; isolated cases of renal impairment or acute renal failure have been reported. Monitor for worsening renal function.
Infusion and Injection Site Reactions: Possible histamine-mediated symptoms have been reported, including rash, pruritus, facial swelling, and vasodilatation. Monitor infusion closely, slow infusion rate if necessary.
The most common adverse reactions across adult and pediatric clinical trials for all indications included diarrhea, nausea, vomiting, abdominal pain, pyrexia, thrombocytopenia, neutropenia, and headache. In pediatric patients younger than 4 months of age, the following additional common adverse reactions were reported at an incidence rate of ≥15%: sepsis, acidosis, anemia, oxygen saturation decreased, and hypokalemia.
INDICATIONS AND USAGE
MYCAMINE® is an echinocandin indicated in adult and pediatric patients for:
- Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older.
- Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age.
- Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older.
- Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing Hematopoietic Stem Cell Transplantation (HSCT).
LIMITATIONS OF USE
- The safety and effectiveness of MYCAMINE have not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age as a higher dose may be needed.
- MYCAMINE has not been adequately studied in patients with endocarditis, osteomyelitis or meningoencephalitis due to Candida.
- The efficacy of MYCAMINE against infections caused by fungi other than Candida has not been established.
Please see full MYCAMINE Prescribing Information.
Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. For more information, please visit our website at: https://www.astellas.com/us/.
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.
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.
i Greenberg, R. G., & Benjamin, D. K., Jr (2014). Neonatal candidiasis: diagnosis, prevention, and treatment. The Journal of infection, 69 Suppl, S19–S22. doi:10.1016/j.jinf.2014.07.012
ii The Centers for Disease Control and Prevention. Invasive Candidiasis Statistics. Last reviewed: November 13, 2019. Accessed December 4, 2019. https://www.cdc.gov/fungal/diseases/candidiasis/invasive/statistics.html.
iii Tsay S, Williams S, Mu Y, et al. National Burden of Candidemia, United States, 2017. Open Forum Infect Dis. 2018;5(Suppl 1):S142-43.
iv MYCAMINE® (micafungin for injection) [package insert]. Northbrook, IL: Astellas Pharma US, Inc.
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