
Information Request Email, June 26, 2014 - BEXSERO

 
 
RECORD OF TELEPHONE CONVERSATION

Submission Type: BLA     Submission ID: 125546/0     Office: OVRR 

Product:
 Meningococcal Group B Vaccine 

Applicant:
 Novartis Vaccines and Diagnostics, Inc. 

Telecon Date/Time: 26-Jun-2014 03:26 PM     Initiated by FDA? Yes

Telephone Number: 

Communication Categorie(s): 
 1. Information Request

Author: KIRK PRUTZMAN

Telecon Summary: 
IR regarding including AESIs in the ISS

FDA Participants: KIRK PRUTZMAN, ED WOLFGANG, RAMACHANDRA NAIK

Non-FDA Participants: PATRICIA STOEHR

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body: 


From: Prutzman, Kirk C
 Sent: Thursday, June 26, 2014 3:21 PM
 To: Stoehr, Patricia (patricia.stoehr@novartis.com)
 Cc: Naik, Ramachandra; Wolfgang, Edward
 Subject: STN 125546 - Information Request

Dr. Stoehr,

We have the following request for additional information regarding STN 125546 (Recombinant Meningococcal Group B Vaccine):

1. If not done already, please provide an additional analysis of adverse events of special interest (AESIs) in the ISS, including those pertaining to autoimmune conditions. A tabulation of all AESIs (categorized by MedDRA term(s), length of follow-up, temporal relationship to vaccination, and assessed relationship to study vaccine) should be included. Please do not delay submitting the final piece of your rolling BLA to include this analysis in your ISS. If you are not able to include this information in your ISS before submitting it in the last installment of your BLA, it may be submitted as an amendment to the BLA. 


As an example, the following list of AESIs has been provided: 

Gastrointestinal disorders
 Celiac disease 
 Crohns disease
 Ulcerative colitis
 Ulcerative proctitis

Liver disorders
 Autoimmune cholangitis 
 Autoimmune hepatitis
 Primary biliary cirrhosis
 Primary sclerosing cholangitis

Metabolic diseases
 Addisons disease
 Autoimmune thyroiditis (including Hashimoto thyroiditis)
 Diabetes mellitus type I
 Grave's or Basedows disease 

Musculoskeletal disorders
 Antisynthetase syndrome
 Dermatomyositis 
 Juvenile chronic arthritis (including Stills disease)
 Mixed connective tissue disorder 
 Polymyalgia rheumatic
 Polymyositis
 Psoriatic arthropathy
 Relapsing polychondritis
 Rheumatoid arthritis
 Scleroderma, including diffuse systemic form and CREST syndrome
 Spondyloarthritis, including ankylosing spondylitis, reactive arthritis (Reiter's Syndrome) and undifferentiated spondyloarthritis
 Systemic lupus erythematosus
 Systemic sclerosis

Neuroinflammatory disorders
 Acute disseminated encephalomyelitis, including site specific variants (e.g., non-infectious encephalitis, encephalomyelitis, myelitis, myeloradiculomyelitis)
 Cranial nerve disorders, including paralyses/paresis (e.g., Bells palsy)
 Guillain-Barr syndrome, including Miller Fisher syndrome and other variants
 Immune-mediated peripheral neuropathies and plexopathies (including chronic inflammatory demyelinating polyneuropathy, multifocal motor neuropathy and polyneuropathies associated with monoclonal gammopathy)
 Multiple sclerosis
 Narcolepsy
 Optic neuritis
 Transverse Myelitis

Skin disorders 
 Alopecia areata 
 Autoimmune bullous skin diseases (including pemphigus, pemphigoid and dermatitis herpetiformis)
 Cutaneous lupus erythematosus
 Erythema nodosum 
 Morphoea
 Lichen planus
 Psoriasis
 Sweets syndrome 
 Vitiligo

 Vasculitides
 Large vessels vasculitis including: giant cell arteritis such as Takayasu's arteritis and temporal arteritis.
 Medium sized and/or small vessels vasculitis including: polyarteritis nodosa, Kawasaki's disease, microscopic polyangiitis, Wegener's granulomatosis, ChurgStrauss syndrome (allergic granulomatous angiitis), Buergers disease thromboangiitis obliterans), necrotizing vasculitis and anti-neutrophil cytoplasmic antibody (ANCA) positive vasculitis (type unspecified), Henoch- Schonlein purpura, Behcet's syndrome, leukocytoclastic vasculitis

 Others
 Antiphospholipid syndrome 
 Autoimmune hemolytic anemia
 Autoimmune glomerulonephritis (including IgA nephropathy, glomerulonephritis rapidly progressive, membranous glomerulonephritis, membranoproliferative glomerulonephritis, and mesangioproliferative glomerulonephritis)
 Autoimmune myocarditis/cardiomyopathy 
 Autoimmune thrombocytopenia 
 Goodpasture syndrome 
 Idiopathic pulmonary fibrosis
 Pernicious anemia 
 Raynauds phenomenon
 Sarcoidosis 
 Sjgrens syndrome 
 Stevens-Johnson syndrome 
 Uveitis

If you have any questions about this communication, please contact Kirk Prutzman, Ramachandra Naik, or Ed Wolfgang at (301) 796-2640,

Regards,

Kirk Prutzman, PhD
 Primary Reviewer/Regulatory Project Manager 
 CBER/OVRR/DVRPA/CMC3 
 Food and Drug Administration
 10903 New Hampshire Avenue
 Building 71 and Room 3041
 Silver Spring, MD 20993-0002
 Phone: (301) 796-2640
 Fax: (301) 595-1244
