GAITHERSBURG, Md., July 18 /PRNewswire-FirstCall/ -- MedImmune, Inc.
(Nasdaq: MEDI) announced today that the U.S. Food and Drug Administration
(FDA) has issued a Complete Response Letter (CRL) for a supplemental biologics
license application (sBLA) related to the new formulation of FluMist
(Influenza Virus Vaccine Live, Intranasal) for the current approved
indication. With the sBLA, MedImmune is seeking approval to use
refrigerator-stable CAIV-T (cold adapted influenza vaccine, trivalent) in
preventing influenza in healthy individuals 5 to 49 years of age. The FDA is
requesting clarification and additional information relating to data
"Based on our review of the letter received, we expect to fully respond to
the agency within two to four weeks," said Linda J. Peters, senior vice
president, regulatory affairs. "We are confident that our continued
interaction with the FDA will result in approval of the new formulation of our
intranasal vaccine in advance of the 2007-2008 influenza season. CAIV-T will
bring an added level of convenience to administering the vaccine and establish
the basis upon which the company plans to expand the product's label."
MedImmune plans to submit a separate sBLA to the FDA within the next few
weeks requesting an expanded label for FluMist. This sBLA will include data
from a Phase 3 study involving approximately 8,500 children between 6 months
and 59 months of age.
Ms. Peters added, "We remain on track with our plans to launch in time for
the 2007-2008 influenza season an improved formulation of our intranasal
influenza vaccine with an expanded indication down to one year of age."
FluMist is indicated for active immunization for the prevention of disease
caused by influenza A and B viruses in healthy children and adolescents, 5 to
17 years of age, and healthy adults, 18 to 49 years of age. There are risks
associated with all vaccines, including FluMist. Like any vaccine, FluMist
does not protect 100 percent of individuals vaccinated. In studies of people
between the ages of 5 and 49 years, runny nose was the most commonly reported
side effect. Other common side effects included various cold-like symptoms,
such as headache, cough, sore throat, tiredness/weakness, irritability, and
FluMist should not be used, under any circumstances, in anyone with an
allergy to any part of the vaccine, including eggs; in children and
adolescents receiving aspirin therapy; in people who have a history of
Guillain-Barre syndrome; and in people with known or suspected immune system
problems. Pregnant women and people with certain medical conditions, asthma,
or reactive airways disease should not get FluMist.
Please see the Prescribing Information at
http://www.flumist.com/pdf/prescribinginfo.pdf, visit http://www.flumist.com,
or call 1-877-633-4411 for additional information.
CAIV-T is an investigational intranasal, cold-adapted trivalent influenza
vaccine. It is the next-generation, refrigerator-stable formulation of
FluMist, which is a frozen, live attenuated cold-adapted trivalent influenza
vaccine. To date, the safety, tolerability and efficacy of CAIV-T has been
studied in both healthy and at-risk populations between the ages of 6 weeks
and 98 years.
About MedImmune, Inc.
MedImmune strives to provide better medicines to patients, new medical
options for physicians, rewarding careers to employees, and increased value to
shareholders. Dedicated to advancing science and medicine to help people live
better lives, the company is focused on the areas of infectious diseases,
cancer and inflammatory diseases. With more than 2,300 employees worldwide,
MedImmune is headquartered in Maryland. For more information, visit the
company's website at http://www.medimmune.com.
This announcement contains, in addition to historical information, certain
"forward-looking statements" regarding the regulatory approval process and
development plans for CAIV-T. Such forward-looking statements are based on
current expectations and involve inherent risks and uncertainties, including
factors that could delay, divert or change current expectations and could
cause actual outcomes and results to differ materially from current
expectations. In addition to risks and uncertainties discussed in
MedImmune's filings with the U.S. Securities and Exchange Commission, no
assurance exists that development efforts for CAIV-T will succeed, that CAIV-T
will receive required regulatory approval or that, even if regulatory approval
is received, CAIV-T will be commercially successful. MedImmune undertakes no
obligation to update any forward-looking statement, whether as a result of new
information, future events or otherwise except as may be required by
applicable law or regulation.
SOURCE MedImmune, Inc.
CONTACT: Media, Clarencia Stephen, +1-301-398-4073 or Jamie Lacey,
+1-301-398-4035, Investors, Pete Vozzo, +1-301-398-4358, all of MedImmune,