According
to study, “Primary Immune Deficiency (PID)
- Pipeline Review, H2 2018” some of the major players that are working in the primary
immune deficiency are Biotest AG, Cellective Bio TherapyInc, ADMA Biologics Inc,
Casebia Therapeutics, Genethon SA, GC Pharma, GigaGenIncm, Novartis AG, Leadiant
Biosciences Inc, Octa pharma AG, Sangamo Therapeutics Inc, ProMetic Life
Sciences Inc, Shire Plc, Therapure BiopharmaInc, Taiga Biotechnologies Inc, UCB
SA, X4 Pharmaceuticals Inc.
Primary
immunodeficiency (PTD) is a large group of disorders in which part of the
body's immune system is missing or does not function normally. It allows
infections and other health problems to occur more easily. Some forms of PID
are usually hereditary while some disorders are not recognized until adulthood.
There are many signs and symptoms of deficiency such as blood disorders,
digestive problems, delayed growth & development, autoimmune disorders,
frequent & recurrent pneumonia, ear& skin
infection and inflammation & infection of internal organs etc.
PIDs
are classifies into many categories according to the component of the immune
system such as T cell deficiencies, B cell deficiency, combination B & T
cell deficiency, complement deficiencies and idiopathic growth hormone deficiency
etc. T cell deficiency is caused by decreased function of individual T cell. T
cell’s normal function is to help with the human body’s immunity. B cell
deficiency is caused by a lack of infection-fighting producing B cells or immunoglobulin
that is not functioning properly. Combined B-cell and T-cell immunodeficiency is
a group of medical disorders that are the result of genetic defects in cellular
and humoral immunity, also called severe combined immunodeficiency.
There
are many complications are involved in PID such as recurrent infections,
autoimmune disorders, damage to (heart, lungs, nervous system or digestive
tract), slowed growth, increased risk of cancer and death from serious
infection. There are many drug profiles are involved in primary immune
deficiency, which are; BT-595, aldesleukin, cell therapyfor RAG deficient,
cellular immunotherapy, gene therapy for x-linked SCID, elapegademase, gene
therapy to activate IL2RG for x-linked SCID, hyaluronidase & immune
globulin, OTL-101, RI-002, RPL-201, seletalisib, stem cell therapy to activate
IL2RG for SCID-X1, TBX-1400, strimvelis and X-4P001.
BIVIGAM
is an intravenous immune globulin indicated for the treatment of primary humeral
immunodeficiency. It includes agammaglobulinemia, Wiskott-Aldrich syndrome and
severe combined immunodeficiency. BIVIGAM is a purified, sterile, ready-to-use
preparation of concentrated polyclonal immunoglobulin antibodies. Antibodies
are proteins in the human immune system that work to defend against infections
and disease. In June 2018, ADMA optimized the production process for BIVIGAM
and submitted a prior approval supplement to the United States food & drug
administration to amend the biologics license application with a target action under
the prescription drug user fee act. If prior approval supplement is approved by
the food & drug administration. The immunodeficiency can be subtle and vary
in presentation which involves recurrent or unusual infections, malignancies or
autoimmune phenomena.Primary care providers assess and treat PID's patients a
clinical immunologist can advise on further diagnostic tests and management of
patients. Collaborative patient care among health care providers can save
patient lives and improve long-term outcomes.
At
present, there is no single assay that identifies all forms of PID. Therefore
need a challenge of current newborn screening paradigms andit is estimated that
PID will involve up-front next generation sequencing.
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