Date: 2017-05-24
Type of information: Granting of a Market Authorisation in the EU
Product name: Trumenba® - rLP2086
Compound: meningococcal B vaccine
Therapeutic area: Infectious diseases
Action mechanism:
- vaccine. This investigational meningococcal B vaccine targets LP2086, or factor H binding protein, which is found on the surface of the meningococcal B bacterium. The gene for factor H binding protein is present in more than 1,800 meningococcal B isolates studied by Pfizer researchers. The vaccine contains two recombinant versions of the LP2086 antigen, one representative for each of the two known genetic subfamilies of the antigen, subfamily A and subfamily B.
- Pfizer is conducting a global clinical development program for bivalent rLP2086, which includes both Phase 2 and Phase 3 trials evaluating more than 20,000 participants, approximately 14,000 of whom will receive the investigational vaccine. The Phase 3 program began in November 2012 with the initiation of a large scale safety study. Additional immunogenicity and safety studies are also ongoing.
Company: Pfizer (USA - NY)
Disease: prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B
Latest news:
- • On March 23, 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Trumenba®, intended for prophylaxis against invasive meningococcal disease caused by meningococcal serogroup B
bacteria. Trumenba® will be available as a suspension for injection. Immunisation with Trumenba® is intended to stimulate the production of bactericidal antibodies that recognize fHbp expressed by meningococci.
The benefits with Trumenba® are its ability to induce protective serum bactericidal antibody responses to a
number of meningococcal serogroup B test strains expressing fHbp variants that are representative of meningococcal serogroup B strains causing invasive disease. The most common side effects are injection site local reactions (pain, redness and swelling), headache, fatigue, chills, diarrhoea, muscle and joint pain, and nausea.
- • On October 29, 2014, the FDA announced the approval of Trumenba®, the first vaccine licensed in the United States to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. Meningococcal disease can be treated with antibiotics to reduce the risk of death or serious long-term problems, but immediate medical attention is extremely important. Vaccination is the most effective way to®ed four of the five main serogroups of N. meningitidis bacteria that cause meningococcal disease: A, C, Y, and W. Three randomized studies were conducted in the United States and Europe in approximately 2,800 adolescents. Among study participants who received three doses of Trumenba®, after vaccination, 82 percent had antibodies in their blood that killed four different N. meningitidis serogroup B strains compared with less than 1 percent before vaccination. These four strains are representative of strains that cause serogroup B meningococcal disease in the United States. The safety of Trumenba® was assessed in approximately 4,500 individuals who received the vaccine in studies conducted in the United States, Europe and Australia. The most commonly reported side effects by those who received Trumenba® were pain and swelling at the injection site, headache, diarrhea, muscle pain, joint pain, fatigue and chills.The FDA used the accelerated approval regulatory pathway to approve Trumenba®.
- • On August 14, 2014, Pfizer announced that the FDA has accepted for review the Biologics License Application (BLA) for bivalent recombinant LP2086 (rLP2086), the company’s vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10 through 25 year olds. The FDA has also granted Priority Review designation for the BLA, providing an anticipated Prescription Drug User Fee Act (PDUFA) action date of February 14, 2015.
- • On June 17, 2014, Pfizer announced that it has submitted a Biologics License Application (BLA) to the FDA for bivalent recombinant LP2086 (rLP2086), the company’s vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10 to 25 year olds. The FDA has a 60-day filing review period to determine whether the BLA is complete and acceptable for filing. Pfizer will communicate the agency’s decision.
- The FDA granted Breakthrough Therapy designation for bivalent rLP2086 in March 2014 based, in part, on data from clinical trials studying the safety and immunogenicity of bivalent rLP2086. Clinical data from a Phase 2 study published in the Lancet Infectious Diseases in 2012 showed the investigational bivalent rLP2086 vaccine induced bactericidal antibodies in healthy adolescents aged 11 to 18 years that were broadly active against meningococcal B bacteria. Safety data from the study also showed the vaccine had an acceptable safety profile in this healthy adolescent study population and supported the further evaluation of the vaccine in Phase 3 studies. Additionally, in two Phase 2 studies presented at the Annual Meeting of the European Society for Paediatric Diseases (ESPID) in May 2014, bivalent rLP2086 was found to elicit bactericidal responses against diverse meningococcal serogroup B test strains.
Patents:
Submission of marketing authorization application USA : 2014-06-17
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2014-10-29
UE authorization: 2017-05-24
Favourable opinion UE: 2017-03-23
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
