FluMistTreatment for Influenza Prophylaxis
FDA Advisory Committee Recommends Expanded Use of FluMist
GAITHERSBURG, Md., May 16, 2007 /PRNewswire-FirstCall/ -- MedImmune, Inc. today announced that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted in favor of expanding the population for use of FluMist (Influenza Virus Vaccine Live, Intranasal) to include children under 5 years of age. The committee voted that the data demonstrate the efficacy of FluMist in children 6 to 59 months of age. In addition, the committee voted in favor of the risk-benefit profile of FluMist in children 12 to 59 months of age without a history of wheeze, and voted in favor of the risk-benefit profile of FluMist in children 24 to 59 months of age regardless of a history of wheeze.
"We are very pleased with the committee's endorsement to expand the availability of FluMist to children under 5 years of age," said Edward M. Connor, M.D., executive vice president and chief medical officer. "Pending approval, we believe that FluMist will be an important new alternative for helping to protect this group of vulnerable children from influenza. We look forward to continuing discussions with the FDA in its review of our application."
FluMist, a nasal spray vaccine, is currently approved for healthy children and adolescents 5 to 17 years of age and healthy adults 18 to 49 years of age. The FDA is expected to respond to the company's supplemental biologics licensing application (sBLA) requesting an expanded indication for FluMist in children below 5 years of age by May 28, 2007.
Advisory committees are expert panels who provide the FDA with independent opinions and recommendations on applications related to new and currently marketed drugs, biologics, vaccines and FDA policies. All final decisions related to a regulated product are made by the FDA.
During today's FDA advisory meeting, the questions voted on by the committee and the resulting votes are described below:
- Do the data demonstrate the efficacy of FluMist for prevention of influenza illness in the following:
a. The applicant's proposed population, i.e., children age 12-59 months without history of wheeze? Vote: 15-0 in favor
b. Children in the age strata 6-23 months? Vote: 14-1 in favor
c. Children in the age strata 24-59 months? Vote: 15-0 in favor
- Do the safety data demonstrate that the benefits will exceed the risks of FluMist for use in:
a. The applicant's proposed population, i.e., children age 12-59 months without history of wheeze? Vote: 9-6 in favor
b. Children in the age strata 6-23 months, regardless of wheezing history? Vote: 3-12 against
c. Children in age strata 24-59 months, regardless of wheezing history? Vote: 15-0 in favor
A third question solicited advice from the panel regarding post-marketing studies and surveillance activities.
FluMist is currently 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. As with any vaccine, FluMist does not protect 100 percent of individuals vaccinated and may not protect against viral strains not contained in the vaccine.
Under no circumstances should FluMist be administered as an injection (i.e. parenterally). FluMist is contraindicated in persons with hypersensitivity to any component of the vaccine, including eggs; in children and adolescents receiving aspirin therapy or aspirin-containing therapy; in individuals with a history of Guillain-Barre syndrome; and in individuals with known or suspected immune deficiency. The safety and efficacy of FluMist have not been established in pregnant women or for patients with chronic underlying medical conditions, including asthma or reactive airways disease; the vaccine should not be administered to these patients.
In randomized, placebo-controlled clinical trials of FluMist in its refrigerated and frozen formulations, the most common solicited adverse events in the indicated population (n=11,604) included runny nose/nasal congestion, sore throat, cough, irritability, headache, chills, vomiting, muscle aches, decreased appetite, abdominal pain, and decreased activity/feeling of tiredness/weakness.
On January 5, 2007, the FDA approved MedImmune's sBLA for a refrigerated version of FluMist, which will be manufactured for the 2007-2008 influenza season. Prior versions required frozen storage. Due to the seasonal nature of influenza vaccine, full prescribing information for the refrigerated version does not yet contain complete details on vaccine strains to be included for next season's vaccine.
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 2,500 employees worldwide, MedImmune is headquartered in Maryland. For more information, visit the company's website at www.medimmune.com.
This announcement contains, in addition to historical information, certain "forward-looking statements" regarding the potential prospects of and the results of clinical trials for FluMist. 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 FluMist will receive required regulatory approval for children 12 months to 59 months of age or that, even if regulatory approval is received, FluMist 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.
Notice to Investors and Stockholders of MedImmune
This release is neither an offer to purchase nor a solicitation of an offer to sell shares of MedImmune. MedImmune stockholders are urged to read the relevant tender offer documents from AstraZeneca PLC which have been filed on May 3, 2007 because they contain important information that stockholders should consider before making any decision regarding tendering their shares. AstraZeneca has filed tender offer materials with the U.S. Securities and Exchange Commission, and MedImmune has also filed a Solicitation/Recommendation Statement on Schedule 14D-9 with respect to the offer. The tender offer materials (including an Offer to Purchase, a related Letter of Transmittal and certain other offer documents) and the Solicitation/Recommendation Statement contain important information, which should be read carefully before any decision is made with respect to the tender offer. The Offer to Purchase, the related Letter of Transmittal and certain other offer documents, as well as the Solicitation/Recommendation Statement, are available for free at the U.S. Securities and Exchange Commission's web site at www.sec.gov, at AstraZeneca's website at www.astrazeneca.com or at MedImmune's website at www.medimmune.com.
CONTACT: Media - Karen Lancaster, +1-301-398-5864 or +1-240-832-9720onsite May 16, or Jamie Lacey, +1-301-398-4035; Investors - Pete Vozzo,+1-301-398-4358 or +1-301-252-7518 onsite May 16, or Beatrice Pierre,+1-301-398-4905, all of MedImmune, Inc.
Ticker Symbol: (NASDAQ-NMS:MEDI)
Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company
Posted: May 2007
- FDA Approves FluMist Quadrivalent Vaccine to Prevent Seasonal Influenza - March 1, 2012
- FluMist MedImmune Vaccines, Inc - Treatment for Prevention of Influenza - June 17, 2003