Date: 2012-03-02
Type of information:
Product name: Imvamune® - Imvanex® in Europe.
Compound: smallpox vaccine
Therapeutic area:
Action mechanism: vaccine. The active substance of Imvamune® - Imvanex® is Modified Vaccinia Ankara virus – Bavarian Nordic (MVA-BN) live virus. It is a live attenuated virus which works by inducing the immune system to produce antibodies against the smallpox virus. It will be available as a suspension for subcutaneous injection. As opposed to traditional smallpox vaccines, it is non-replicating which means that it does not proliferate in the body.
Company: Bavarian Nordic (Denmark)
Disease: smallpox infection prevention
Latest news: * On August 7, 2013, Bavarian Nordic has announced that the European Commission has granted marketing authorization for Imvanex® (MVA-BN) for active immunization against smallpox disease for the general adult population, including people with weakened immune systems (people diagnosed with HIV or atopic dermatitis). The authorization covers all 27 European Union member states and European Economic Area countries Iceland, Liechtenstein and Norway. Known as Imvamune® in the U.S., it has been developed under contracts with the U.S. Government. To-date, Bavarian Nordic has manufactured and delivered 17 million doses of the vaccine to the U.S. Strategic National Stockpile for emergency use in immune compromised individuals, such as people with atopic dermatitis and HIV who are not recommended to receive conventional, replicating smallpox vaccines. IMVANEX has also been supplied to other government stockpiles around the world.* On May 30, 2013, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a marketing authorization for Imvanex® for active immunization against smallpox disease for the general adult population, including people with immunodeficiencies (people diagnosed with HIV or atopic dermatitis). The CHMP recommended that Imvanex® be used for primary vaccination (individuals previously not vaccinated against smallpox) or booster vaccination (for individuals previously vaccinated against smallpox) and can also be used in immunocompromised people. The CHMP decided that Imvanex’s benefits are greater than its risks following the assessment of five main studies involving healthy and immunocompromised people. The studies showed that Imvanex was effective at stimulating an immune response against MVA-BN when used as primary or as booster vaccination. However, due to the rarity of the condition and the fact that clinical trials cannot be carried out, comprehensive data on the efficacy and safety was not available at the time of the assessment and the CHMP therefore recommended that Imvanex be approved for use in the EU under exceptional circumstances.The vaccine was filed for marketing authorization through a centralized procedure, supported by clinical data in more than 3,400 people.* On March 1, 2012 , Bavarian Nordic announced that it has submitted a MAA to the EMA for its smallpox vaccine ( Imvamune®) that will be marketed under the trade name Imvanex® in Europe. The MAA has been filed for consideration under the centralized procedure and following a successful review could potentially lead to the market authorization of Imvanex® in Europe (EAA countries) during 2013. If found acceptable by EMA, Imvanex® will be indicated for active immunization against smallpox infection and disease in persons 18 years of age and older. The indication will include individuals with immune deficiencies and skin disorders such as those who are Human Immunodeficiency Virus (HIV) infected and those diagnosed with Atopic Dermatitis (AD).
* On March 30, 2011, Bavarian Nordic announced that it has submitted a marketing authorization application (MAA) in Canada for its smallpox vaccine candidate Imvamune®. The MAA has been filed as a standard New Drug Substance (NDS) submission to Health Canada based on clinical indicators of efficacy.
Bavarian Nordic was awarded a Request for Proposal (RFP) in December 2008 by the Canadian Government to supply Imvamune® to the Canadian armed forces. As part of this contract, Bavarian Nordic was requested to evaluate the potential for licensing Imvamune® in Canada. In October 2009, Bavarian Nordic consulted with the agency during a pre-NDS advice meeting. Based on the data presented, Health Canada encouraged Bavarian Nordic to submit a standard NDS application, outlining the clinical indicators of efficacy for Imvamune®.
If found acceptable by Health Canada following a standard NDS review time of approximately one year, Imvamune® will be indicated for active immunization against smallpox infection and disease in persons 18 years of age and older. The indication will include individuals with immune deficiencies and skin disorders such as those who are Human Immunodeficiency Virus (HIV) infected and those who have Atopic Dermatitis (AD). The vaccine may be used for both primary vaccination and re-vaccination, both in an emergency and non-emergency setting.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE: 2012-03-01
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization: 2013-08-07
Favourable opinion UE: 2013-05-30
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
