FDA Licenses Interferon Beta-1b

NEWS 07/23/1993 FDA Licenses Interferon Beta-1b
P93-31                             Food and Drug Administration
FOR IMMEDIATE RELEASE              Monica Revelle (301) 443-4177

     The Food and Drug Administration today announced the licensing
of Interferon beta-1b, the first product for the treatment of
certain patients with multiple sclerosis and the first
biotechnology product to be licensed under FDA's accelerated
approval regulations.
     Multiple sclerosis is a chronic, often disabling disease of
the central nervous system that occurs when a protective sheath
surrounding the nerve fibers breaks down.  Nearly 30 percent of
multiple sclerosis patients suffer from a relapsing-remitting form
of the disease in which symptoms disappear totally or partially
after a flare-up and are followed by a period of stability that can
last for months or years.
     A clinical trial involving 372 patients with relapsing-
remitting multiple sclerosis indicated that administration of
Interferon beta-1b by injection every other day decreased the
frequency of flare-ups and kept more patients free of flare-ups
over a two-year treatment period.
     "This product marks an important first," said FDA Commissioner
David A. Kessler, M.D.  "It's not a cure, but it will help relieve
debilitating symptoms for many multiple sclerosis patients for whom
no other relief is available.

      "We gave this drug a top-priority review," he said.   "This 
demonstrates our commitment to act quickly to make drugs available
to those who need them."
     The accelerated approval policy allows for expediting the
approval of therapies that provide a meaningful therapeutic benefit
for patients with serious illnesses.  It enables FDA to approve 
therapies as soon as their safety and effectiveness can be
reasonably established.
     Accelerated approval relies solely or in part on "surrogate
endpoints" -- laboratory measurements or physical signs -- for
evidence of effectiveness.  The surrogate endpoints are believed to
be likely to predict benefit for the patient.
     The surrogate endpoints used in licensing Interferon beta-1b
were data from magnetic resonance imaging (MRI) scans of the brain,
which supported the clinical findings.  MRI scans indicated that
after two years of treatment, there was a greater increase in the
multiple sclerosis lesion areas in the brains of patients treated
with a placebo than in patients treated with Interferon beta-1b. 
The trials did not demonstrate, however, that the findings on MRI
scans correlate with slower disease progression.  
     The accelerated approval regulations require the product's
manufacturer, Chiron Corp. of Emeryville, Calif., to conduct
postmarketing studies to investigate the effectiveness of
Interferon beta-1b in slowing or preventing progression of multiple
sclerosis.
     Adverse reactions following administration of Interferon beta-
1b included inflammation and pain at the injection site and flu-
like symptoms.  The use of other types of interferon has also been
associated with occasional serious side effects including abnormal
liver function tests and severe depression, including suicidal
depression.  These events were also observed in multiple sclerosis
patients taking Interferon beta-1b in clinical trials. 
     An estimated 250,000 to 350,000 Americans are affected by 
multiple sclerosis, which affects twice as many women as men.  Two
thirds of the patients experience their first symptoms between the
ages of 20 and 40.
     On March 19, the Peripheral and Central Nervous System Drugs
Advisory Committee recommended approval of Interferon beta-1b for
decreasing the frequency of flare-ups in patients with relapsing-
remitting multiple sclerosis. 
     On June 3, FDA sent an "approvable" letter that informed
Chiron Corp. that the agency was prepared to approve the product
when certain conditions were met.  Chiron then submitted the
requested information and made a commitment to conduct
postmarketing studies.
     Interferon beta-1b is manufactured by Chiron under the trade
name "Betaseron."  Berlex Laboratories of Alameda, Calif., will
distribute it.
     FDA is one of eight Public Health Service agencies within HHS.
                                


            MILESTONES IN BETASERON APPROVAL PROCESS

     Betaseron was licensed under the accelerated approval policy.

 o   Biologics licensed in the normal process take an average of 28
     months for FDA review of the Product License Application
     (PLA).  The FDA review of Betaseron, including intensive
     discussions and presentation of more data, took just 12
     months.

 o   Betaseron is the first biotechnology product licensed under
     the accelerated approval process.  It was preceded by DDC, a 
     drug for AIDS, which was approved under the same program last
     year.  

 o   The review of the PLA for Betaseron was the first
     collaborative effort on a marketing application by the Center
     for Biologics Evaluation and Research and the Center for Drug
     Evaluation and Research.


                         IMPORTANT DATES

March 3, 1983       Investigational New Drug Application filed

Nov. 11, 1988       FDA designates Betaseron as an Orphan Drug

July 23, 1992       Chiron Corp. files the PLA with FDA

March 19, 1993      Peripheral and Central Nervous System Drugs
                    Advisory Committee recommends approval

May 30, 1993        FDA completes its review of the PLA 

June 3, 1993        FDA sends Chiron "Approvable Letter" 

July 23, 1993       FDA licenses Betaseron