Committee for Medicinal Products for Human Use Summary of Positive Opinion for Optaflu
LONDON, April 26, 2007-On 26 April 2007 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion,** recommending to grant a marketing authorisation for the medicinal product Optaflu suspension for injection, intended for prophylaxis of influenza for adults, especially in those who run an increased risk of associated complications. The applicant for this medicinal product is Novartis Vaccines and Diagnostics GmbH & Co. KG.
The active substances of Optaflu are the purified influenza virus antigens of type A (H1N1), type A (H3N2) and type B strains. The composition of the influenza strains will be those officially recommended for the season.
Optaflu is a trivalent influenza vaccine (J07BB02) that induces an immune response (circulating antibodies) against the antigens (i.e. A/H3N2, A/H1N1, and B strains). The duration of postvaccinal immunity to strains included in the vaccine varies but is usually 6-12 months, as proven by studies performed during the clinical development of this vaccine.
The benefit of Optaflu is its protection against seasonal influenza. The most common side effects are local reactions (redness, pain, swelling), headache, malaise, fatigue, fever and myalgia, usually disappearing within 1-2 days without treatment.
A pharmacovigilance plan for Optaflu, as for all medicinal products, will be implemented as part of the marketing authorisation.
The approved indication is: "prophylaxis of influenza for adults, especially in those who run an increased risk of associated complications".
Detailed recommendations for the use of this product will be described in the Summary of Product Characteristics (SPC), which will be published in the European Public Assessment Report (EPAR) and will be available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
The CHMP, on the basis of quality, safety and efficacy data submitted, considers that there is a favourable benefit to risk balance for Optaflu and therefore recommends the granting of the marketing authorisation.
* Summaries of positive opinion are published without prejudice to the Commission Decision, which will normally be issued within 67 days from adoption of the Opinion.
** Applicants may request a re-examination of any CHMP opinion, provided they notify the EMEA in writing of their intention to request a re-examination within 15 days of receipt of the opinion.