GAITHERSBURG, Md., July 18 /PRNewswire-FirstCall/ -- MedImmune, Inc. (Nasdaq: MEDI - News) 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 previously submitted.
“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.”
About FluMist
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 muscle aches.
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.
About CAIV-T
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.
