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Biological
Products Approved under Subpart E
Under Subpart E, approval
may be based on a surrogate endpoint or on an effect on a
clinical endpoint other than survival or irreversible
morbidity ("Surrogate") [21 CFR 601.41], or a product may be
approved with restrictions to assure safe use ("Restricted")
[21 CFR 601.42]. (See Table below)
[21 CFR 601.41] Surrogate -
Approval based on a surrogate endpoint or on an effect on a
clinical endpoint other than survival or irreversible
morbidity.
FDA may grant marketing approval for
a biological product on the basis of adequate and
well-controlled clinical trials establishing that the
biological product has an effect on a surrogate endpoint
that is reasonably likely, based on epidemiologic,
therapeutic, pathophysiologic, or other evidence, to predict
clinical benefits or on the basis of an effect on a clinical
endpoint other than survival or irreversible
morbidity. Approval under this section will be subject
to the requirement that the applicant study the biological
product further, to verify and describe its clinical
benefit, where there is uncertainty as to the relation of
the surrogate endpoint to clinical benefit, or of the
observed clinical benefit to ultimate outcome.
Postmarketing studies would usually be studies already
underway. When required to be conducted, such studies
must also be adequate and well-controlled. The
applicant shall carry out any such studies with due
diligence.
[21 CFR 601.42] Restricted -
Approval with restrictions to assure safe
use.
(a) If FDA concludes that a
biological product shown to be effective can be safely used
only if distribution or use is restricted, FDA will require
such postmarketing restrictions as are needed to assure safe
use of the biological product, such as:
(1) Distribution restricted to
certain facilities or physicians with special training or
experience; or (2) Distribution conditioned on the
performance of specified medical procedures. (3) The
limitations imposed will be commensurate with the specific
safety concerns presented by the biological
product. |
BLAs approved under Subpart E through June 2005
Submission Tracking # |
Proprietary Name |
Proper
Name |
Receipt Date |
Approval Date |
AP
Time |
Approval Basis |
Indication |
BL125104 |
Tysabri |
natalizumab |
24-May-04 |
23-Nov-04 |
5.97 |
S |
Treatment of patients
with relapsing forms of multiple sclerosis to reduce the frequency of
clinical exacerbations |
125084 |
Erbitux |
cetuximab |
14-Aug-03 |
12-Feb-04 |
5.95 |
S |
Treatment of
EGFR-expressing, metastatic colorectal carcinoma in patients
who are refractory to irinotecan-based chemotherapy (in
combination with irinotecan); Treatment of EGFR-expressing,
metastatic colorectal carcinoma in patients who are intolerant
to irinotecan-based chemotherapy (administered as a single
agent)
|
103979 |
Fabrazyme |
agalsidase
beta |
23-Jun-00 |
24-Apr-03 |
34.05 |
S |
Use in patients
with Fabry disease to reduce globotriaosylceramide (GL-3)
deposition in capillary endothelium of the kidney and certain
other cell types
|
125019 |
Zevalin |
ibritumomab
tiuxetan |
1-Nov-00 |
19-Feb-02 |
15.58 |
S |
Treatment of
patients with relapsed or refractory low grade, follicular, or
transformed B-cell non-Hodgkin's lymphoma
|
103948 |
Campath |
alemtuzumab |
23-Dec-99 |
7-May-01 |
16.5 |
S |
Treatment of
B-cell chronic lymphocytic leukemia (B-CLL) in patients who
have been treated with alkylating agents and who have failed
fludarabine therapy
|
103767 |
Ontak |
denileukin
diftitox |
9-Dec-97 |
5-Feb-99 |
13.88 |
S |
Treatment of
persistent or recurrent cutaneous T-cell lymphoma |
103772 |
Remicade |
infliximab |
30-Dec-97 |
24-Aug-98 |
7.8 |
S |
Treatment of
moderately to severely active Crohn's disease for the
reduction of the signs and symptoms, in patients who have an
inadequate response to conventional therapies and treatment of
patients with fistulizing Crohn's disease for the reduction in
the number of draining enterocutaneous
fistula(s)
|
103471 |
Betaseron |
interferon
beta-1b |
18-Jun-92 |
23-Jul-93 |
13.16 |
S |
Treatment of
multiple sclerosis
|
The Therapeutic
Biologic Products listed above were transferred from CBER to CDER
effective 1-Oct-03.
R - Restricted - Approval with
restrictions to assure safe use as recorded in 21 CFR 601.42
(Subpart E)
S - Surrogate - Approval based on a
surrogate endpoint or on an effect on a clinical endpoint
other than survival or irreversible morbidity as recorded in
21 CFR 601.41 (Subpart E) |
Updated quarterly through 6/30/05
Date created: July 5, 2005
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