Release date: 2018-03-20
Recently, CSL Behring announced that the US FDA has approved the launch of its new drug Hizentra (human immunoglobulin subcutaneous injection, 20%) as the first subcutaneous drug immunoglobulin for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). Protein therapy to prevent disability and damage in patients with neuromuscular recurrence.
CIDP is a rare autoimmune disease that affects the peripheral nerves outside the brain and spinal cord. In patients with this disease, the myelin sheath that protects the nerve will be damaged, causing muscle numbness, weakness, fatigue and other symptoms. As the disease continues, the symptoms of CIDP will be further aggravated, greatly limiting the patient's ability to exercise and reducing their quality of life. It is estimated that 30% of patients will be in a wheelchair if they do not receive proper treatment. Given the severity of the disease, effective treatments are expected to greatly improve the quality of life of patients.
Hizentra approved today is such a new drug. This is a human immunoglobulin subcutaneous injection (20%) that has been approved in more than 51 countries around the world to treat specific immunodeficiencies. Since 2010, the drug has proven its safety, efficacy, and tolerability in more than 4.8 million uses.
The FDA approval is based on a positive result from a clinical trial called PATH. The study showed that patients receiving Hizentra, regardless of the proportion of recurrence of CIDP, or the proportion of patients who could not continue to receive subcutaneous injections of human immunoglobulin, were significantly lower than the control group. In addition, subcutaneously injected immunoglobulins cause fewer systemic side effects than intravenously infused immunoglobulins. Overall, 93% of the infusions did not show any side effects in the 4225 Hizentra infusions.
“The latest FDA approval for Hizentra is an important milestone for patients with CIDP,†said Dr. Andrew Cuthbertson, CSL's Chief Scientific Officer and Director of Research and Development. “As the first and only subcutaneous injection for CIDP. Immunoglobulin therapy, which has been validated in the largest CIDP clinical trial. Hizentra provides a proven, more effective treatment option for patients. Patients can self-inject at home. CSL Behring promises to be as rare as CIDP Innovative therapies for patients with serious illnesses. We are proud to offer immunoglobulin therapy for the treatment of CIDP today."
“Despite other treatment options, many patients with CIDP are still plagued by daily illnesses. Therefore, ongoing research and innovation are necessary,†said Ms. Lisa Butler, Executive Director of GBS|CIDP Foundation International: “Hizentra approved Allowing patients to no longer need to travel long distances to the hospital to receive an infusion. They have the flexibility to self-heal at any time, anywhere, according to their own convenience."
We congratulate the launch of this new therapy and expect it to bring life improvements to many patients with CIDP.
Source: WuXi PharmaTech (Wei Signal WuXiAppTecChina)
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