FDA Approves Pediatric Indication for Astellas' MYCAMINE® (micafungin sodium) for Injection

FDA Approves Pediatric Indication for Astellas' MYCAMINE® (micafungin sodium)
                                for Injection

PR Newswire

NORTHBROOK, Ill., June 24, 2013

NORTHBROOK, Ill., June 24, 2013 /PRNewswire/ --Astellas Pharma US, Inc.
("Astellas"), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo:
4503), announced that the U.S. Food and Drug Administration (FDA) has approved
its Supplemental New Drug Application (sNDA) for the use of MYCAMINE®
(micafungin sodium) for injection by intravenous infusion for the treatment of
pediatric patients four months and older with candidemia, acute disseminated
candidiasis, Candida peritonitis and abscesses, esophageal candidiasis, and
prophylaxis of Candida infections in patients undergoing hematopoietic stem
cell transplants (HSCT).

"We are pleased with FDA's approval of MYCAMINE for use in pediatric patients
four months and older," said Sef Kurstjens, M.D., chief medical officer,
Astellas Pharma, Inc. "This expanded indication supports the safety and
efficacy of MYCAMINE and delivers on our mission to provide treatments that
can help to improve patient care."

"Candida infections are a significant concern to pediatric healthcare
professionals, and there are limited treatment options," said Antonio C.
Arrieta, M.D., Director Pediatric Infectious Diseases, Children's Hospital of
Orange County and Clinical Professor, Pediatrics, University of California,
Irvine. "Because MYCAMINE has been shown to be safe and effective in treating
candidemia in many adult patients, it is an important new option for treating
Candida infections in pediatric patients age four months and older."

Safety and effectiveness of MYCAMINE in pediatric patients four months and
older have been demonstrated based on the evidence from adequate and
well-controlled studies in adult and pediatric patients and additional
pediatric pharmacokinetic and safety data. Two randomized, double-blind,
active controlled studies investigated the safety and efficacy of MYCAMINE in
both adult and pediatric patients: one for the treatment of invasive
candidiasis and candidemia, and the other for prophylaxis of Candida
infections in patients undergoing HSCT. Safety and effectiveness of MYCAMINE
in patients younger than four months of age have not been established.

The overall safety of MYCAMINE was assessed in 479 patients, ages three days
through 16 years, who received at least one dose of MYCAMINE in 11 separate
clinical trials. The mean treatment duration was 24.8 days. In all pediatric
studies with MYCAMINE, 439 of 479 (92%) patients experienced at least one
treatment-emergent adverse reaction. The most common (≥15%) TEAEs observed in
all MYCAMINE-treated pediatric patients age four months and older were:
vomiting (31%), diarrhea (22%), pyrexia [fever (22%)], nausea (19%), abdominal
pain (16%) and thrombocytopenia [low blood platelet levels (15%)].

MYCAMINE dosage in pediatric patients age four months and older is as follows:

Indication                               Pediatric Dose Given Once Daily
                                         30 kg or less Greater than 30 kg
Treatment of Candidemia, Acute           2 mg/kg
Disseminated Candidiasis, Candida
Peritonitis and Abscesses                (maximum daily dose 100 mg)
                                                       2.5 mg/kg
Treatment of Esophageal Candidiasis      3 mg/kg
                                                       (maximum daily dose 150
                                                       mg)
Prophylaxis of Candida Infections in     1 mg/kg up to 50 mg
HSCT Recipients

About Candida and Candida Infections
Candida is a type of yeast that causes common fungal infections. Candida
normally lives on the skin without illness, however, overgrowth and
compromised immune systems can lead to symptoms of infection. Candidemia
occurs when Candida enters the bloodstream, which can lead to spread of the
infection to other parts of the body.

Candida species are the third most common cause of pediatric health care
associated bloodstream infection.

About MYCAMINE (micafungin sodium) for Injection
MYCAMINE is a member of a class of antifungal agents, the echinocandins.
MYCAMINE inhibits an enzyme essential for fungal cell-wall synthesis and is
fungicidal (lethal) for Candida.

Indications and Usage:
MYCAMINE is indicated in adults and pediatric patients four months and older
for:

  oTreatment of patients with candidemia, acute disseminated candidiasis,
    Candida peritonitis and abscesses.

       oMYCAMINE has not been adequately studied in patients with
         endocarditis, osteomyelitis and meningitis due to Candida infections

  oTreatment of patients with esophageal candidiasis
  oProphylaxis of Candida infections in patients undergoing hematopoietic
    stem cell transplantation

       oNOTE: The efficacy of MYCAMINE against infections caused by fungi
         other than Candida has not been established.

MYCAMINE was approved in 2005 for the treatment of adult patients with
esophageal candidiasis and in 2008 for use in adult patients with candidemia,
acute disseminated candidiasis, Candida peritonitis and abscesses. MYCAMINE
is the only echinocandin antifungal agent approved for the prophylaxis of
Candida infections in adult, and now pediatric, patients undergoing HSCT.

Important Safety Information for MYCAMINE® (micafungin sodium) for Injection
MYCAMINE is contraindicated in patients with known hypersensitivity to
micafungin sodium, any component of MYCAMINE, or other echinocandins.

Isolated cases of serious hypersensitivity (anaphylaxis and anaphylactoid)
reactions (including shock) have been reported in patients receiving
MYCAMINE. In these cases, MYCAMINE should be discontinued and administer
appropriate treatment.

Elevations in BUN and creatinine, isolated cases of clinically significant
hepatic dysfunction, hepatitis, hepatic failure, renal dysfunction, acute
renal failure, hemolysis, or hemolytic anemia have occurred in some patients
who have received MYCAMINE. Patients who develop these conditions, or
abnormal liver or renal function tests, should be monitored closely for
worsening function and evaluated for risk/benefit of continuing MYCAMINE
therapy.

In clinical trials, possible histamine-mediated symptoms have been reported
with MYCAMINE (including rash, pruritus, facial swelling, and vasodilatation).

In clinical trials, the most common treatment-emergent adverse reactions in
adults for all indications included diarrhea, nausea, vomiting, pyrexia,
thrombocytopenia, and headache. The most common treatment-emergent adverse
reactions observed in pediatric patients four months and older included
vomiting, diarrhea, pyrexia, nausea, abdominal pain and thrombocytopenia.

Please see complete Prescribing Information for MYCAMINE.

About Astellas Pharma US, Inc.
Astellas Pharma US, Inc., located in Northbrook, Illinois, is a U.S. affiliate
of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company
dedicated to improving the health of people around the world through the
provision of innovative and reliable pharmaceutical products. The
organization is committed to becoming a global category leader in focused
areas. For more information about Astellas Pharma US, Inc., please visit our
website at www.astellas.us.

SOURCE Astellas Pharma US, Inc.

Website: http://www.astellas.us
Contact: Jenny Kite, Astellas, +1-847-682-4530 cell, Jenny.Kite@astellas.com