New Drug Approvals in 1992

NDA FDA REVIEW FOREIGN
DRUG COMPANY INDICATIONIUSE RECEIVED* APPROVED TIME AVAILABILITY
Vumon~ Bristol-Myers Squibb acute lymphoblastic 9/28/90 7/14/92 21.5 months 33 countries
teniposide (New York, NY) leukemia (ALL) including:
(P) 1975 Switzerland
1979 Sweden
1979 Germany
1980 France
DESCRIPTION: For the treatment of refractory childhood acute lymphoblastic leukemia (ALL), in combination with other 1984 Canada
approved anticancer medicines. (Contact: Robert F. Laverty, 609/252-5551) 1988 Denmark
ZebetaTM Lederle Laboratories hypertension 8/1/89 7/31/92 36.0 months 23 countries
bisoprolol (Wayne, NJ) including:
fumarate 1986 Germany
(S) 1987 France
1987 Switzerland
1988 Spain
1988 UK
DESCRIPTION: For the treatment of mild to moderate hypertension. (Contact: Pat Fiaschetti, 201/831-4684) 1990 Japan

JA Ap

Dves 6 Biologic Therapeutics and Vaccines

By Thomas L. Copmann, Ph.D.
Assistant Vice President for Biotechnology and Biologics
Pharmaceutical Manufacturers Association

The Food and Drug Administration
approved 6 important biologics in
1992-4 therapeutics and 2
vaccines. Average approval time for
the biologics approved in 1992 was
35.3 months. Biologics are products
based on naturally occurring substances,
most of which are reviewed and
approved by the Center for Biologics
Evaluation and Research (CBER) at FDA.
Of the 1992 approvals, 3 of the 4
therapeutics are made using genetic
engineering: OncoScint CR/OV by
Cytogen, Proleukin by Chiron, and
Recombinate by Baxter Healthcare.
Two of these 3 biotechnology-based
products are cancer-related and 1 is a
hemophilia treatment.
Proleukin is an interleukin and the
only FDA-approved medicine for the
treatment of metastatic kidney cancer.
It focuses the power of the body's immune system directly on cancer cells.
Interleukins are naturally occurring
substances in the body. White blood
cells, involved in ridding the body of
diseased cells, are exposed to interleukin to make them more effective in
finding and destroying cancer cells.

OncoScint CR/OV, an imaging agent
to diagnose colorectal or ovarian
cancer, uses monoclonal antibodies,
which are highly specific laboratoryproduced versions of the natural antibodies the immune system produces to
fight disease. The monoclonal antibodies are tagged with a radioactive
substance. When injected into the
patient, they seek out and bind to
cancer cells. A gamma camera detects
the radioactive substance and pinpoints
the location and extent of the disease.
Recombinate is for the prevention
and treatment of hemophilia A, a rare
hereditary disorder caused by the
absence or deficiency of factor VIII,
a human blood clotting factor. The
disorder causes uncontrolled bleeding,
which can lead to severe muscle and
joint damage and even death. An estimated 17,000 to 20,000 U.S. males
suffer from the disorder. Recombinate
is derived through genetic engineering
technology and manufactured in tissue
culture, as opposed to being extracted
from human blood. This eliminates the
risk of transmitting human viruses such
as HIV and hepatitis.

The fourth biologic therapeutic is
Mononine by Armour, indicated for
the prevention and control of bleeding
in factor IX deficiency, also known as
hemophilia B or Christmas disease. It
has been designated as an orphan drug
to treat hemophilia B, which is a rare
disease that affects about 4,000 people
in the United States. Although Mononine
is not a product of genetic engineering,
monoclonal antibodies are used to
separate factor IX from other blood
plasma proteins.
The vaccines approved are Tripedia
by Connaught Laboratories and JE-VAX
by Connaught and The Research Foundation for Microbial Diseases of Osaka
University. JE-VAX provides immunization against Japanese encephalitis (JE)
and is indicated for military personnel
and others traveling to endemic areas.
JE is a mosquito-borne viral disease
that can cause a fatal inflammation of
the brain. Tripedia, Connaught's
diphtheria, tetanus toxoids and pertussis
(DTP) vaccine, is for use in children
ages 17 months to 7 years.