BIO with the FDA '02 scorecard:
>>WASHINGTON, Jan. 9 /PRNewswire/ -- The Food and Drug Administration (FDA) approved 35 new biotechnology-based drugs and vaccines as well as new indications for previously approved products in 2002, up slightly from 2001, according to an analysis by the Biotechnology Industry Organization (BIO).
"More than half of the 168 biotech medicines available to patients and on the market today, were approved in just the last five years, demonstrating the steadily accelerating growth of the biotech industry," said Carl B. Feldbaum, BIO president.
Of the 35 FDA approvals issued last year, 20 were for new medicines designed to treat such diseases as osteoporosis, hepatitis C, pulmonary arterial hypertension, cancer and multiple sclerosis.
"The increase in the number of FDA biotechnology product approvals last year means that many patients with debilitating and life-threatening illnesses now have their first-ever therapies and cures, and many others have vastly improved medical options available to them," Feldbaum said. "More than 350 biotech products are in late-stage development for 200 serious diseases, and many of these represent significant medical advancements for patients suffering from conditions such as asthma, diabetes and HIV infection."
"The Prescription Drug User Fee Act, which was renewed last year, should help reduce review and approval times at the FDA. With that law in place and a new Commissioner leading the agency, the drug approval process will continue to improve," Feldbaum concluded.
The Biotechnology Industry Organization (BIO) represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S. states and 33 other nations. BIO members are involved in the research and development of health-care, agricultural, industrial and environmental biotechnology products. For more information on BIO, visit our Web site at bio.org.
For a bar graph on Biotech Drug and Vaccine Approvals since 1982, please visit bio.org.
Biotech Drug Approvals 2002*
Total: 35
New products: 20
New indications: 15
New Products
Product Company Application (use) Approval
date
AVINZA(TM) Ligand Pharmaceuticals Once-daily treatment of March
(extended- and Elan Corp. plc moderate to severe pain 2002
release in patients who require
morphine continuous opioid
sulfate) therapy for an extended
period of time
Eligard(TM) Atrix Laboratories Advanced prostate January
(slow-release and cancer 2002
formulation Sanofi-Synthelabo
of leuprolide
acetate)
Elitek(TM) Sanofi-Synthelabo Management of plasma July
(rasburicase) uric acid levels in 2002
pediatric chemotherapy
patients
FortaFlex(TM) Organogenesis Inc. Rotator cuff repair April
(bioengineered and Biomet Inc. 2002
collagen
matrix)
FORTEO(R) Eli Lilly and Company Treatment of November
(teriparatide, osteoporosis in 2002
recombinant) postmenopausal women
at high risk of
fracture, and to
increase bone mass in
men with primary or
hypo-gonadal
osteoporosis who are
at high risk of fracture
Hepsera(TM) Gilead Sciences Inc. Chronic hepatitis B September
(adefovir 2002
dipivoxil)
HUMIRA(TM) Cambridge Antibody Patients with December
(adalimumab) Technologies and moderately to severely 2002
Abbott Laboratories active rheumatoid
arthritis who have had
insufficient response to
one or more traditional
disease modifying
antirheumatic drugs
Imagent(R) Alliance Imaging agent for use June
(perflexane Pharmaceutical Corp., in echocardiography 2002
lipid Cardinal Health
microspheres) and InChord
Communications Inc.
INFUSE(TM) Wyeth and For use in spinal July
Bone Graft/ Medtronic Sofamor fusion surgery to treat 2002
LT-CAGE(TM) Danek certain types of spinal
(device degenerative disease
utilizing
recombinant
human bone
morphogenetic
protein
[rhBMP-2])
Mitozytrex SuperGen Inc. Disseminated November
(MitoExtra(TM); adenocarcinoma of the 2002
proprietary stomach or pancreas
version of
mitomycin)
Neulasta(TM) Amgen Reduction of incidence January
(pegfilgrastim) of infection as 2002
manifested by febrile
neutropenia in
nonmyeloid cancer
patients receiving
certain chemotherapies
Orfadin(R) Swedish Orphan Hereditary tyrosinemia January
(nitisinone) International AB and type 1 2002
Rare Disease
Therapeutics Inc.
Pediarix(TM) GlaxoSmithKline Prevention of December
(diphtheria diphtheria, tetanus, 2002
and tetanus pertussis, hepatitis B
toxoids and and polio
acellular
pertussis ad-
sorbed,
hepatitis B
[recombinant]
and
inactivated
polio-virus
vaccine
combined)
Pegasys(R) Roche and Inhale Chronic hepatitis C October
(peginterferon Therapeutics Inc. patients with 2002
alfa-2a) compensated liver
disease who have not
been previously
treated with
alpha interferon
Rebif(R) Serono SA and Relapsing forms of March
(interferon Pfizer Inc. multiple sclerosis 2002
beta 1-a)
Remodulin(TM) United Therapeutics Treatment of pulmonary May 2002
(treprostinil Corp. arterial hypertension
sodium) in patients with NYHA
Class II-IV symptoms to
diminish symptoms
associated with exercise
RESTASIS(TM) Allergan Inc. Chronic dry eye disease December
(cyclosporine in patients whose tear 2002
ophthalmic production is presumed
emulsion) to be suppressed due to
ocular inflammation
SecreFlo(TM) Repligen Corp. Pancreatic assessment April
(synthetic 2002
porcine
secretin)
Xyrem(R) Orphan Medical Inc. Cataplexy associated July
(sodium with narcolepsy 2002
oxybate)
Zevalin(TM) IDEC Relapsed or refractory February
(ibritumomab Pharmaceuticals low-grade, follicular 2002
tiuxetan) Corp. or transformed B-cell
non-Hodgkin's lymphoma
New Indications
Aranesp(TM) Amgen Chemotherapy-induced July
(darbepoietin anemia in patients with 2002
alfa) non-myeloid malignancies
Argatroban Texas Biotechnology Anticoagulant for use April
Corp. and in patients with or at 2002
GlaxoSmithKline risk of heparin-induced
thrombo-cytopenia
undergoing
percutaneous coronary
interventions
AVAGE(TM) Allergan Inc. Topical treatment of October
(tazarotene; facial fine wrinkling, 2002
also marketed mottled hypo- and
as Tazorac(R)) hyperpigmentation, and
benign facial lentigines
BOTOX(R) Allergan Inc. Temporary improvement April
COSMETIC in appearance of 2002
(botulinum moderate to severe
toxin type A) glabellar lines
(frown lines) in
adults 65 or younger
ENBREL(R) Amgen and Wyeth Reduction of signs and January
(etanercept) symptoms of active 2002
arthritis in patients
with psoriatic
arthritis
FOLLISTIM(TM) Organon (unit of Induction of spermato- February
(follitropin Akzo Nobel) genesis in men with 2002
beta) primary and secondary
hypo-gonadotropic
hypogonadism in whom
the cause of infertility
is not due to a primary
testicular failure
Gleevec(TM) Novartis AG Treatment of Kit February
(imatinib (CD117) positive 2002;
mesylate) unresectable and/or December
metastatic malignant 2002
gastrointestinal tumors;
first-line treatment of
adult patients with newly
diagnosed Philadelphia
chromosome-positive
chronic myeloid leukemia
INTEGRA(R) Integra LifeSciences Repair of scar April
Dermal Holding Corp. and contractures 2002
Regeneration Ethicon Inc. (unit of
Template Johnson & Johnson)
OLUX(R) Connetics Corp. Short-term topical December
Foam treatment of mild to 2002
(clobetasol moderate plaque-type
proprionate) psoriasis of non-scalp
regions excluding the
face and intertriginous
areas
Pegasys(R) Roche and Inhale Combination therapy December
(peginterferon Therapeutics Inc. with ribavirin in 2002
alfa-2a) patients with chronic
hepatitis C who have
compensated liver
disease and have not
been previously treated
with alpha interferon
Prevnar(R) Wyeth Immunization of infants October
(pneumococcal and toddlers against 2002
7-valent con- otitis media caused by
jugate vaccine serotypes
vaccine
[diphtheria
CRM-197
protein])
REMICADE(R) Centocor Inc. Improving physical February
(infliximab) (subsidiary of function in patients 2002;
Johnson & Johnson) with moderately June
to severely active 2002
rheumatoid arthritis
who have had an
inadequate response to
methotrexate; reducing
signs and symptoms, and
inducing and maintaining
clinical remission in
patients with moderately
to severely active
Crohn's disease who
have had an inadequate
response to conventional
therapy
SecreFlo(TM) Repligen Corp. Aid in location and November
(synthetic cannulation of 2002
porcine pancreatic ducts in
secretin) patients undergoing
endoscopic retrograde
cholangio-
pancreatography
Sources:
BioCentury Publications, BioCentury
BioWorld Publishing Group, BioWorld Today
CenterWatch.com
Recombinant Capital, Inc./Signalsmag.com
U.S. Food and Drug Administration (FDA)
* Note: This list includes novel biologics developed by biotechnology
companies and pharmaceutical companies, as well as small-molecule
products developed by biotechnology companies, and other selected small-
molecule, delivery-enhanced or tissue-engineered products. For a
complete listing of FDA approvals from 1996 to the present, visit the
agency's Web site at fda.gov. Please direct questions or
comments to Debbie Strickland at (202) 962-9200.<<
Cheers, Tuck |
