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FDA
Grants Full Approval to Serono's Serostim (recombinant growth hormone)
for Treatment of AIDS-related Wasting
 Serono
announced on 8/29/03 that the US Food and Drug Administration (FDA)
has granted full approval for Serostim [somatropin; recombinant
growth
hormone for injection], which is indicated for the treatment
of HIV patients with wasting or cachexia to increase lean body mass
and body weight, and improve physical endurance.
In April 2003,
the European Medicines Evaluation Agency rejected Serono's application
to market Serostim for AIDS-related wasting syndrome.
FDA granted
Serostim accelerated approval in 1996, a special regulatory status
granted by the FDA for approval of a drug that is used to treat
patients with serious or life-threatening illnesses, and provides
meaningful therapeutic benefit over any existing treatments.
Under the terms
of the accelerated approval, Serono conducted a multi-center, confirmatory
placebo-controlled study with Serostim. Data from this trial substantiate
previous study findings of increased lean body mass and improvement
in physical endurance with Serostim. In addition, patients in this
study perceived an improvement in their wasting symptoms with Serostim
treatment.
“We
are very pleased that the FDA has granted full approval for Serostim®,”
said James Sapirstein, Executive Vice President, Metabolic Endocrinology,
Serono, Inc. “Wasting continues to be a major concern in the management
of HIV and AIDS treatment, even with the benefits of HAART. Serostim
makes an important and positive difference in the physical endurance
of people experiencing HIV wasting.”
HIV-associated
wasting is a chronically debilitating and potentially life-threatening
condition. It is a metabolic disorder that causes the body to use
vital muscle and organ tissue, which is critical for survival, for
energy instead of primarily using the body’s stored fat. Loss of
lean body mass, which consists of muscle tissue, important body
organ tissue and blood cells, can lead to increased risk of opportunistic
infections, illness, and extreme fatigue and can profoundly diminish
a person’s quality of life. Serostim was granted orphan drug designation
by the FDA in 1991 for this condition.
Clinical
Study of Serostim in AIDS Wasting
The full approval
of Serostim is
based on results of a randomized, double-blind, dose-ranging study
that confirmed the clinical efficacy of Serostim in the treatment
of HIV wasting. The study treated 757 patients with HIV-associated
wasting at US, European and other international trial sites. Participants
were treated with placebo, Serostim on alternate days (0.1 mg/kg)
or Serostim on a daily basis (0.1 mg/kg).
The result
on the study’s primary endpoint of cycle work output was statistically
significant for the Serostim daily dose group as compared to the
placebo group (p<0.0001). Positive results were also seen for
the secondary endpoint of change in lean body mass for the Serostim
daily dose group as compared to the Serostim
alternate day group (p=0.017) and as compared to the
placebo group (p<0.0001). In addition, patient perception of
the impact of treatment on their wasting symptoms was positive with
both doses of Serostim.
All study participants
completing the 12-week placebo-controlled phase of the trial (n=646)
continued treatment into an extension phase; 548 of these patients
completed an additional 12 weeks of active treatment. In these
patients, positive results in cycle work output and lean body mass
either improved further or were maintained with continued treatment
with Serostim.
Additional
Product Information
Serostim [somatropin
(rDNAorigin) for injection] is the only growth hormone approved
by the FDA for the treatment of HIV wasting or cachexia. The recommended
dose is 0.1 mg/kg daily (6 mg/day for patients > 55 kg). Serostim
0.1 mg/kg every other day should be
considered as a starting dose in patients thought to be at risk
of certain adverse effects, i.e., glucose intolerance.
Serostim is generally well tolerated. The most common
adverse events associated with Serostim therapy are mild to moderate
muscle and joint pain and swelling/edema, which occur in a dose-related
manner and often subside with continued treatment or dose reduction.
Cases of new
onset impaired glucose intolerance, new onset type 2 diabetes mellitus
and exacerbation of preexisting diabetes mellitus have been reported
in patients receiving Serostim. Some patients develop diabetic
ketacidosis and diabetic coma. In some patients, therapy with Serostim
necessitated initiation or adjustment of anti-diabetic treatment.
Patients with
a history of hyperglycemia or other risk factors for glucose intolerance
should be monitored closely during treatment with Serostim. Transient
increases in glucose levels occur early in treatment and should
be monitored.
Use of growth
hormone is contraindicated in treatment of patients in intensive
care units due to complications following open-heart surgery or
abdominal surgery, multiple accidental trauma or acute respiratory
failure; patients with active neoplasia; and patients with known
hypersensitivity to growth hormone. Serostim must be used in conjunction
with antiretroviral therapy.
Full
prescribing information for Serostim, including important safety
information, is available at www.serostim.com.
Other
HIV and Hepatitis.com news stories on Serostim
09/03/03
Source
Serono Laboratories. Serono’s Serostim
receives full approval from FDA for treatment of AIDS wasting. Press
Release. August 29, 2003.
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