What is Multiple Sclerosis: It is a demyelinating disease, where protecting covers of nerve cells of brain & spinal cord are deteriorated. This, in turn, disturbs the capacity of nervous system’s parts to communicate and terminated as a physical, mental & once a while psychiatric issues with a range of signs & symptoms. General Description: An acculturated IgG1 monoclonal antibody “Alemtuzumab—Lemtrada” is the one which was affirmed for B-cell chronic lymphocytic Leukemia’s treatment. It functions by binding to CD52— located on the surface of B & T cells—lymphocytes (prime mediators in the inflammation process) and facilitates their significant reduction and consequently, it was in the long run observed to be more compelling in the treatment …show more content…
And the post-market study is very essential for the continuous supervising, observation of potential side-effects and to make needed amendments in drug regarding safety and effectiveness. Lemtrada is approved by Europe, Health Canada, & Australian Government however not the USFDA. Lemtrada is a monoclonal antibody that should particularly deplete T & B cells only. Intravenously it is given for the 5 days as 12mg/day and after that 12mg/day for 3 days a year later. The endorsing data ought to incorporate a plausibility of genuine serious life-threatening auto-immune disorder infusion responses (like immune thrombocytopenia, anti-glomerular basement membrane disease)& increased malignancies. In perspective of wholeness, the utilization of Lemtrada ought to be held for individuals who have low or very poor or no acknowledgment to at least 2 …show more content…
As a consequence of a study, investigators have demonstrated Lemtrada to be competent in the treatment of MS, which was likewise recognized by the Advisory Committee (AC). However, USFDA has proposed a double-dummy placebo design with “Rebif” as a competitor. Lemtrada and Rebif have distinctive planning for timing and route of administration, diverse adverse event profiles, there could have been a few odds of bias, however, a rater-blinding was kept up in the trials. Actions were taken to ensure honesty, integrity, and interpretability of results so, the aftereffects of this investigation could be trusted. Phase 2 & 3 studies demonstrated Lemtrada as more compelling in lessening Relapse Rate(RR), a risk of Sustained Accumulation of Disability(SAD) and better Expanded Disability Status Scale(EDSS) score. Adverse events of nausea, headache, rash & some more severe like (Immune Thrombocytopenia Purpura) ITP. Under the implementation of Risk Evaluation and Mitigation Strategy (REMS), the utilization of Lemtrada was identified, monitored and restricted for distribution. It is my advice is to handover an availability of Lemtrada to certified physicians only. As Advisory Committee has voted 17-0, which indicate that the approval of the Lemtrada should not be
Scenario: John is a 4 year-old boy who was admitted for chemotherapy following diagnosis of acute lymphoblastic leukemia (ALL). He had a white blood cell count of 250,000. Clinical presentation included loss of appetite, easily bruised, gum bleeding, and fatigue. Physical examination revealed marked splenomegaly, pale skin color, temperature of 102°F, and upper abdomen tenderness along with nonspecific arthralgia.
Myelin, the common factor in each disease, is a subsatnce that surrounds and insulates axons on some nerve cells, allowing for a faster transporting of signals and proper functioning of the nervous system. A demyelinating disease results in the damage of nerve fibers in the brain and spinal cord due to the myelin sheath being destroyed, which is life threatening.
Physicians must prove that there is no other comparable or satisfactory alternative in order to diagnose, monitor, or treat their patient’s condition or disease. They must also conclude that the potential risk of the product is not greater than the risk of the disease or condition (Expanded Access 1). The FDA must also determine that here have been enough tests done already to provide sufficient evidence as to the safety and effectiveness of the product and its use in the case (Expanded Access 1). In addition, the FDA must also be certain that by providing this product to patients outside of the clinical trial it will not interfere with the clinical trial, and the FDA acceptance of the drug (Expanded Access 1). Another requirement is that the company developing the pharmaceutical product, or the clinical investigator, submits a treatment plan (clinical protocol) for the patient, which must follow the FDA’s regulations for INDs (Investigational New Drug) or IDEs (Investigational Device Exemption Application), which describe the use of the investigational product (Expanded Access 1). Pharmaceutical companies must also submit a draft of the Data Development Plan (Expedited Access Pathway Program).
In my essay today i will write about my belief of who was the strongest president, Abraham Lincoln, George Washington, or Thomas Jefferson. In my opinion i believe that George Washington was our strongest leader. He has many great Features that helped shape the early country. He was the first president of the United States putting a lot of pressure on him.
Multiple Sclerosis (MS) is a condition where myelin forms scar tissue and disfigures nerve impulses. This is an example of a deviation from normal physiology found in the nervous system. MS is the result of the immune system atypically attacking myelin and nerve fibers within the central nervous system (CNS). When the myelin and nerve fiber are damaged, it can cause the signal to be disturbed or disfigured. The damaged scar tissue (sclerosis) gives the disease its name. The symptoms of MS can range anywhere from pain and fatigue to tremors and
This newsletter is designed to help practising pharmacists understand the application of the basis sciences to practice concerning adalimumab. Lots of practical advice is based on pharmaceutical sciences but once you enter practice it can be hard to remember or find out the basis of why we advise patients in specific ways or why you or other health professionals should handle medicines in certain ways.
Most people believe that romantic love should be between two people, but F. Scotts Fitzgerald makes use of the love triangle motif in his novel, The Great Gatsby, to show how deceiving other people only hurts all parties, and the ones most deceived seem to be those looking for love and all of the wrong places.
In conclusion, azathioprine-induced ADRs, non-approval from FDA and the lack of its effectiveness on disability progression are the prime reasons why it has been used only for the MS patients who do not respond to therapy with interferon beta or glatiramer
Multiple Sclerosis, a.k.a MS, is a disease of the central nervous system that interrupts messages that go between the brain and the body. The central nervous system is composed of the brain, optic nerves, and spinal cord; it controls functions of the mind and body such as thoughts and body movement. In MS the body's immune system destroys the Myelin Sheath and the nerve fibers. The Myelin Sheath is the protecting cover that surrounded by the nerve fibers. If the Myelin Sheath or nerve fibers are damaged then the nerve impulses in the central nervous system are compromised. Demyelination is the damaging of the Myelin Sheath, afterward a plaque, which is a hardened patch of tissue, forms over the harmed area. This disruption of nerve
Although the drug in question can be yet insufficiently researched, the disease it potentially treats is usually very well-known and its course understood. Information revolution enabled us to use statistics on large samples and multitude of studies to get reliable information on the probabilities of certain events and disease progression. For those diseases where we can claim with sufficient certainty that short periods without therapy will not significantly harm the subject’s health, the study can be designed to keep the placebo trial period short. This limits the quality of the obtained data only to the initial short-term
Multiple sclerosis is a disease of the central nervous system and the disease functions by using the immune system to attack the body in the CNS targeting the nerve fibers. It focuses on the myelin sheath that covers the nerve fibers damaging them and scaring the fibers. This will cause a disruption of communication that is shared between the brain and the body and eventually will be permanent damage. This process is called demyelination. This disease is difficult to diagnose but if you start seeing signs and symptoms go to the doctor to get professional medical treatment or advice to slow down the process of
Multiple sclerosis is an autoimmune disease that damages the myelin sheaths and nervous cells in the central nervous system. An autoimmune disease is when the body produces antibodies to attack its own tissues. Basically, myelin is a mixture of proteins and phospholipids forming a whitish insulating sheath around many nerve fibers, increasing the speed that impulses are sent. It is made by schwann cells in the peripheral nervous system and oligodendrocytes in the central nervous system. Multiple sclerosis attacks the oligodendrocytes and the myelin sheaths causing some very serious problems for people diagnosed with it. The disease affects motor, sensory, and autonomic nerves and has been seen to affect cognitive functions. Females are affected
described the characteristics and symptoms of this disease and what exact organs it relates to.
system. The characteristics of MS are demyelination and axonal loss. The etiology of MS is
As new medicine is formulated in laboratories, first, biochemical and animal experiments is conducted to determine if it is safe and useful for humans. Next, an application for clinical trial is submitted to Therapeutic Goods Administration (TGA), Australia sponsor must be included. Series of clinical trials are conducted. Only after phase III trial (about 1000-3000 volunteers recruited) satisfies the safety, efficacy, and manufacturing standards set by the TGA that the medicine is approved for sale in Australia. If the approved medicine by TGA is equivalent or better than other drugs with similar effect, it is subsidised by Pharmaceutical Benefits Scheme.