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1993.07.23 :  Licensing of Interferon Beta-1b

Contact:  Monica Revelle (301) 443-4177
July 23, 1993

     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 in 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-lb 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-lb 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-lb.  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 or Interferon beta-lb in slowing or preventing
progression of multiple sclerosis.
      Adverse reactions following administration of Interferon beta-
lb 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 affects including abnormal liver function tests and severe
depression, including suicidal depression.  These events were also observed in
multiple sclerosis patients taking Interferon beta-lb in clinical trials.
     An estimated 250,000 to 350,000 Americans are affected by multiple
sclerosis, which affects twice as 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-lb 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-lb 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.

ù  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.

ù  Betaseron in 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.

ù  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 Now Drug Application Filed
Nov. 11, 1989     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     PDA licenses Betaseron