Seqirus receives FDA approval for FLUAD™ (Influenza Vaccine, Adjuvanted) for adults aged 65 years and older

NOTE TO EDITORS: On July 31, 2015 the CSL Group and its Affiliates acquired the influenza vaccines business of Novartis AG in the U.S. The influenza vaccines business, previously owned by Novartis, is now referred to as Seqirus. The Fluad Marketing Authorization ownership will transfer from Novartis Vaccines and Diagnostics, Inc., to Seqirus post-approval.

-- Fluad, the first adjuvanted seasonal influenza vaccine in the US, is approved for use in adults 65 years of age and older (1)

-- Data from nearly 40 clinical trials demonstrated a strong immune response and an acceptable safety profile for Fluad (1)

-- First approval for Seqirus, the second largest influenza vaccine company in the world

Nov 25, 2015, 10:43 ET from Seqirus, A CSL Company

CAMBRIDGE, Mass., Nov. 25, 2015 /PRNewswire/ -- Seqirus announced today that the US Food and Drug Administration (FDA) has approved Fluad (Influenza Vaccine, Adjuvanted) to help protect those aged 65 years and older against seasonal influenza. Fluad is the first adjuvanted seasonal influenza vaccine approved in the United States; it was specifically developed for the adult population aged 65 and older.1

Fluad is an inactivated influenza vaccine indicated for active immunization of adults aged 65 and older caused by influenza virus subtypes A and B contained in the vaccine.2

"While it's important to vaccinate people against the flu throughout their lives, the FDA approval of Fluad offers healthcare providers and their patients 65 years of age and older, who are at high risk for serious complications, a new option to help protect against influenza," said Gordon Naylor, President of Seqirus. "Not only is Fluad the first adjuvanted seasonal influenza vaccine approved for this population in the US, it is the first approval for Seqirus, the combined organization of bioCSL and the influenza vaccines business of Novartis. The name Seqirus is derived from the phrase 'securing health for all of us.'"

According to the Centers for Disease Control and Prevention (CDC), high-risk groups, including people 65 years and older who are at risk of developing serious complications should ensure that they are vaccinated each year.3 Adults 65 years and older account for more than half of all influenza-related hospitalizations and approximately 90 percent of influenza-associated deaths in the US.3 Furthermore, the CDC reports that in the US, the annual direct costs (e.g., hospitalization, doctors' office visits, medications) of influenza are estimated at $4.6 billion. 4

"Adults aged 65 years and older are at the greatest risk of serious complications from influenza compared with young, healthy adults because the immune system weakens with age," said William Schaffner, M.D., Medical Director at the National Foundation for Infectious Diseases and Professor of Medicine and Preventive Medicine at Vanderbilt University, Nashville, Tennessee. "The approval of an adjuvanted trivalent influenza vaccine provides a new vaccine alternative."

The FDA approval of Fluad was based on the results of the pivotal Phase III study of more than 7,000 adults aged 65 and older and demonstrated an acceptable safety profile. 2 Fluad demonstrated a strong immune response and was shown to be non-inferior in relation to the comparator vaccine for all three vaccine strains on the basis of both seroconversion rates and geometric mean titers (GMTs).2

Fluad is licensed in more than 30 countries, in which 81 million doses have been distributed since it was first approved in 1997. 1

About Seasonal Influenza

Seasonal influenza is a highly communicable, acute viral infection that predominantly attacks the respiratory tract.5 Transmission to others may occur one day before symptoms develop and up to five to seven days after becoming sick.5 Because transmission prior to onset of symptoms can occur, the disease can be easily transmitted to others.5 Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases death.5

The CDC estimates that from the 1976-1977 influenza season to the 2006-2007 influenza season, influenza-associated deaths in the US ranged from a low of about 3,000 to a high of about 49,000 people.5 Influenza seasons are unpredictable; they can begin as early as October and substantial activity can occur as late as April.5,6  The CDC encourages annual vaccination for everyone 6 months of age and older who have no contraindications and recommends that people get vaccinated against influenza as long as the viruses are circulating.5

About Fluad

Fluad is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.2 Fluad is approved for use in persons 65 years of age and older.2

Important Safety Information

INDICATIONS AND USAGE

FLUAD is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD is approved for use in persons 65 years of age and older.2

Approval is based on the immune response elicited by FLUAD. Data demonstrating a decrease in influenza disease after vaccination with FLUAD are not available.2

CONTRAINDICATIONS

Severe allergic reaction to any component of the vaccine, including egg protein, or after a previous dose of any influenza vaccine. 2

WARNINGS AND PRECAUTIONS

  • If Guillain-Barré Syndrome (GBS) has occurred within six weeks of previous influenza vaccination, the decision to give FLUAD should be based on careful consideration of the potential benefits and risks.2
  • The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions in latex sensitive individuals.2

ADVERSE REACTIONS

  • The most common (≥ 10%) local (injection site) adverse reactions observed in clinical studies were injection site pain (25%) and tenderness (21%).2
  • The most common (≥ 10%) systemic adverse reactions observed in clinical studies were myalgia (15%), headache (13%) and fatigue (13%).2

Please see accompanying US Full Prescribing Information for FLUAD.

About Seqirus  

Seqirus, part of the CSL Group, is the new global company created from the combined strength and expertise of bioCSL and the influenza vaccines business formerly owned by Novartis. In July 2015, bioCSL and the influenza vaccines unit of Novartis joined forces to create Seqirus, now the second largest influenza vaccine provider in the world. With extensive research and production expertise and manufacturing plants in the US, UK and Australia, Seqirus is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. Seqirus has a workforce of over 2,000 employees, significant manufacturing capacity, and a commercial presence in 20 countries.

 

References:

1.

Seqirus data on file.

2.

Fluad Package Insert

3.

Centers for Disease Control and Prevention (CDC). What You Should Know and Do this Flu Season If You Are 65 Years and Older. Available at: http://www.cdc.gov/flu/about/disease/65over.htm.
Accessed November 2015.

4.

Centers for Disease Control and Prevention (CDC). Seasonal Influenza in the Workplace. Available at: www.cdc.gov/niosh/topics/flu/activities.html

5.

Centers for Disease Control and Prevention (CDC). Key Facts about Influenza (Flu) and Flu Vaccine. Available at: http://www.cdc.gov/flu/keyfacts.htm. Accessed November 2015

6.

Centers for Disease Control and Prevention (CDC). Influenza Prevention: Information for Travelers. Available at http://www.cdc.gov/flu/travelersfacts.htm. Accessed November 2015

 

Media Contact




Monica Galimberti                                                                         

Natalie de Vane

Global Communications, Seqirus                                            

Corporate Communications, CSL Behring

monica.galimberti@seqirus.com                                            

natalie.devane@cslbehring.com

Phone: +39 335 7440521 (mobile)                                        

Phone: +1 610 878 4468 (direct)

 

SOURCE Seqirus, A CSL Company