Common Variable Immunodeficiency Support Group
Common variable immunodeficiency (CVID) is a group of 20-30 primary immunodeficiencies (PIDs) which have a common set of symptoms but with different underlying causes. CVID's underlying causes are different, but the result of these are that the body doesn't produce sufficient antibodies in response to exposure to pathogens.
CSL Wins U.S. Approval for Immune-Replacement Therapy Hizentra
March 04, 2010, 9:13 PM EST
More From Businessweek
By Catherine Larkin and Simeon Bennett
March 5 (Bloomberg) -- CSL Ltd., the worlds second-biggest maker of treatments derived from blood, won U.S. clearance to sell a weekly immune-replacement therapy for people with genetic disorders that lead to frequent infections.
The Food and Drug Administration announced approval of CSLs Hizentra in a letter to the company posted yesterday on the agencys Web site. The medicine will provide a convenient option for patients who want to treat themselves at home instead of receiving intravenous injections from a doctor, the Melbourne-based drugmaker said in a statement.
Hizentra, also known as IgPro20, contains 20 percent immunoglobulin, or antibodies, and is intended as a replacement for CSLs older Viva
CSL Wins U.S. Approval for Immune-Replacement Therapy Hizentra
March 04, 2010, 9:13 PM EST
More From Businessweek
By Catherine Larkin and Simeon Bennett
March 5 (Bloomberg) -- CSL Ltd., the worlds second-biggest maker of treatments derived from blood, won U.S. clearance to sell a weekly immune-replacement therapy for people with genetic disorders that lead to frequent infections.
The Food and Drug Administration announced approval of CSLs Hizentra in a letter to the company posted yesterday on the agencys Web site. The medicine will provide a convenient option for patients who want to treat themselves at home instead of receiving intravenous injections from a doctor, the Melbourne-based drugmaker said in a statement.
Hizentra, also known as IgPro20, contains 20 percent immunoglobulin, or antibodies, and is intended as a replacement for CSLs older Vivaglobin product, which contains 16 percent and was previously the only self-administered immune treatment approved in the U.S.
We do not expect material market share gains, Andrew Goodsall, a health-care analyst at UBS AG in Sydney, said in a note to clients today. They already have a monopoly in that space. CSLs nearest competitor, Baxter International Inc., is at least three years away from introducing a rival product, he said.
CSL rose 79 Australian cents, or 2.3 percent, to A$35.59 as of 12:43 p.m. in Sydney, the highest since Feb. 27 last year. The benchmark S&P/ASX 200 Index rose 0.5 percent.
Many people with immune deficiencies are children, and frequent infections can cause life-threatening organ damage or death, according to CSL. Infusions of replacement antibodies help supplement the immune system to prevent infections.
CSL submitted its biologic license application on May 1. While the FDA aims to consider most new drugs within 10 months, the agency said reviews may be extended up to a week after last months blizzard shuttered government offices near Washington. Hizentra did not raise concerns or controversial issues that warranted review by outside advisers, the FDA letter said.
--Editors: Donna Alvarado, Andrew Pollack
To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net; Simeon Bennett in Singapore at sbennett9@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net.
Related Articles
globin product, which contains 16 percent and was previously the only self-administered immune treatment approved in the U.S.
We do not expect material market share gains, Andrew Goodsall, a health-care analyst at UBS AG in Sydney, said in a note to clients today. They already have a monopoly in that space. CSLs nearest competitor, Baxter International Inc., is at least three years away from introducing a rival product, he said.
CSL rose 79 Australian cents, or 2.3 percent, to A$35.59 as of 12:43 p.m. in Sydney, the highest since Feb. 27 last year. The benchmark S&P/ASX 200 Index rose 0.5 percent.
Many people with immune deficiencies are children, and frequent infections can cause life-threatening organ damage or death, according to CSL. Infusions of replacement antibodies help supplement the immune system to prevent infections.
CSL submitted its biologic license application on May 1. While the FDA aims to consider most new drugs within 10 months, the agency said reviews may be extended up to a week after last months blizzard shuttered government offices near Washington. Hizentra did not raise concerns or controversial issues that warranted review by outside advisers, the FDA letter said.
--Editors: Donna Alvarado, Andrew Pollack
To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net; Simeon Bennett in Singapore at sbennett9@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net.
Related Articles
March 04, 2010, 9:13 PM EST
More From Businessweek
By Catherine Larkin and Simeon Bennett
March 5 (Bloomberg) -- CSL Ltd., the worlds second-biggest maker of treatments derived from blood, won U.S. clearance to sell a weekly immune-replacement therapy for people with genetic disorders that lead to frequent infections.
The Food and Drug Administration announced approval of CSLs Hizentra in a letter to the company posted yesterday on the agencys Web site. The medicine will provide a convenient option for patients who want to treat themselves at home instead of receiving intravenous injections from a doctor, the Melbourne-based drugmaker said in a statement.
Hizentra, also known as IgPro20, contains 20 percent immunoglobulin, or antibodies, and is intended as a replacement for CSLs older Viva
CSL Wins U.S. Approval for Immune-Replacement Therapy Hizentra
March 04, 2010, 9:13 PM EST
More From Businessweek
By Catherine Larkin and Simeon Bennett
March 5 (Bloomberg) -- CSL Ltd., the worlds second-biggest maker of treatments derived from blood, won U.S. clearance to sell a weekly immune-replacement therapy for people with genetic disorders that lead to frequent infections.
The Food and Drug Administration announced approval of CSLs Hizentra in a letter to the company posted yesterday on the agencys Web site. The medicine will provide a convenient option for patients who want to treat themselves at home instead of receiving intravenous injections from a doctor, the Melbourne-based drugmaker said in a statement.
Hizentra, also known as IgPro20, contains 20 percent immunoglobulin, or antibodies, and is intended as a replacement for CSLs older Vivaglobin product, which contains 16 percent and was previously the only self-administered immune treatment approved in the U.S.
We do not expect material market share gains, Andrew Goodsall, a health-care analyst at UBS AG in Sydney, said in a note to clients today. They already have a monopoly in that space. CSLs nearest competitor, Baxter International Inc., is at least three years away from introducing a rival product, he said.
CSL rose 79 Australian cents, or 2.3 percent, to A$35.59 as of 12:43 p.m. in Sydney, the highest since Feb. 27 last year. The benchmark S&P/ASX 200 Index rose 0.5 percent.
Many people with immune deficiencies are children, and frequent infections can cause life-threatening organ damage or death, according to CSL. Infusions of replacement antibodies help supplement the immune system to prevent infections.
CSL submitted its biologic license application on May 1. While the FDA aims to consider most new drugs within 10 months, the agency said reviews may be extended up to a week after last months blizzard shuttered government offices near Washington. Hizentra did not raise concerns or controversial issues that warranted review by outside advisers, the FDA letter said.
--Editors: Donna Alvarado, Andrew Pollack
To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net; Simeon Bennett in Singapore at sbennett9@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net.
Related Articles
globin product, which contains 16 percent and was previously the only self-administered immune treatment approved in the U.S.
We do not expect material market share gains, Andrew Goodsall, a health-care analyst at UBS AG in Sydney, said in a note to clients today. They already have a monopoly in that space. CSLs nearest competitor, Baxter International Inc., is at least three years away from introducing a rival product, he said.
CSL rose 79 Australian cents, or 2.3 percent, to A$35.59 as of 12:43 p.m. in Sydney, the highest since Feb. 27 last year. The benchmark S&P/ASX 200 Index rose 0.5 percent.
Many people with immune deficiencies are children, and frequent infections can cause life-threatening organ damage or death, according to CSL. Infusions of replacement antibodies help supplement the immune system to prevent infections.
CSL submitted its biologic license application on May 1. While the FDA aims to consider most new drugs within 10 months, the agency said reviews may be extended up to a week after last months blizzard shuttered government offices near Washington. Hizentra did not raise concerns or controversial issues that warranted review by outside advisers, the FDA letter said.
--Editors: Donna Alvarado, Andrew Pollack
To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net; Simeon Bennett in Singapore at sbennett9@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net.
Related Articles
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