
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 
• Crohn’s disease
• Ulcerative colitis
• Ulcerative proctitis

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

Metabolic diseases
• Addison’s disease
• Autoimmune thyroiditis (including Hashimoto thyroiditis)
• Diabetes mellitus type I
• Grave's or Basedow’s disease 

Musculoskeletal disorders
• Antisynthetase syndrome
• Dermatomyositis 
• Juvenile chronic arthritis (including Still’s 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., Bell’s palsy)
• Guillain-Barré 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
• Sweet’s 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, Churg–Strauss syndrome (allergic granulomatous angiitis), Buerger’s 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 
• Raynaud’s phenomenon
• Sarcoidosis 
• Sjögren’s 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
