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DEPARTMENT

OF HEALTH 81HUMAN SERVICES

PUBLK:HEALTHSERWX Food and Drug Administration

Memorandum

Center for Biologics Evaluation

and Research

1401 Rockvile

Pike

Rockville, MD

20852

Division of Clinical Trial Design and Analysis HFM-576

Date:

19

August

2002

From: Cynthia A. Rask, M.D.

Subject: STN 103628/5021

Through:

Marc

K. Walton,

M.D.,

Ph.Dfl

To:

Melanie Hartsough, BLA STN 103628/5021

Ph.D., sBtA study file

review

committee

chair

I have reviewed

the clinical study report for Biogen’s study C980844.

Assessment

and

The overall

safety

Conclusions: profile for the

liquid

HSA-free

Avoneti

Biogen

Study

C94-844

is

not

substantially

or

meaningfully

formulation different

administered from that reported

in

with

the use of the commercially

available

lyophilized

Avonex@ used in previous

clinical

studies

and in clinical practice. This conclusion

is based on

Avonex@

along

with

pre-

and

post-marketing

safety

the current package reports, taking into

insert

for

account

the

different

patient populations

in which the two formulations

have been used, the varying

durations

of exposure

and

serum

neutralizing

to the drug, and the frequency antibodies.

of ascertainment

of adverse

reactions

Attached is my review.

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