FDA 阐明 Gilead Sciences公的新型Hiv药
WASHINGTON (Reuters Health) - Biopharmaceutical firm Gilead Sciences Inc. said on Monday that it has received approval from the US Food and Drug Administration (FDA) to market its antiretroviral agent Viread (tenofovir disoproxil fumarate) for the treatment of HIV in combination with other antiretroviral agents.
More than 900,000 Americans are infected with HIV, for which the most commonly prescribed treatment is the use of several antiretroviral agents such as Viread to delay the onset of symptoms.
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Like Viread, many of these drugs work by blocking the process needed for HIV replication in the body. But Viread is the first nucleotide analogue reverse transcriptase inhibitor to be approved for treatment of HIV in the US. As a result, experts say that it may offer an important treatment option for those patients that have become resistant to the currently available medications.
"The drug has demonstrated a significant antiviral response, even in patients who may no longer respond well to available therapies due to the development of viral resistance," explained Dr. Calvin Cohen, research director for Community Research Initiative of New England and Harvard Vanguard Medical Associates, in a prepared statement.
, 百拇医药
Experts also believe that Viread may prove an important option due to its once-a-day dosing regimen.
In clinical trials, Viread reduced the level of circulating HIV by about 75%. The most common side effects included nausea, diarrhea, vomiting and flatulence.
Foster City, California-based Gilead said that the 300 mg tablet should be available within a few days. The company added that it would be indicated for use in combination with other antiretroviral agents for the treatment of previously diagnosed patients.
, 百拇医药
Gilead said that it was conducting additional studies to evaluate Viread in combination with other antiretroviral agents for treatment-naive patients as well as children. The company estimated that about 350,000 Americans presently receive antiretroviral agents, and that another 15,000 patients begin treatment each year.
Earlier this year, Gilead also applied for marketing approval in Europe and Australia. Gilead said that it anticipates the European approval decision to be made in early 2002.
, 百拇医药
On Monday morning, Robertson Stephens analysts Michael King and Dr. Steven Harr raised their sales estimates for Viread, saying that the FDA approval indication was "broader than we expected." The analysts raised their 2002 sales estimates for the drug from $75 million to $125 million and their 2004 estimate from $275 million to $300 million.
In a research note, King and Harr wrote, "We believe [Gilead] will likely target all HIV patients receiving treatment immediately upon launch."
In Monday afternoon trading on the NASDAQ, shares of Gilead slipped 1.62 to 66.06., 百拇医药
More than 900,000 Americans are infected with HIV, for which the most commonly prescribed treatment is the use of several antiretroviral agents such as Viread to delay the onset of symptoms.
, http://www.100md.com
Like Viread, many of these drugs work by blocking the process needed for HIV replication in the body. But Viread is the first nucleotide analogue reverse transcriptase inhibitor to be approved for treatment of HIV in the US. As a result, experts say that it may offer an important treatment option for those patients that have become resistant to the currently available medications.
"The drug has demonstrated a significant antiviral response, even in patients who may no longer respond well to available therapies due to the development of viral resistance," explained Dr. Calvin Cohen, research director for Community Research Initiative of New England and Harvard Vanguard Medical Associates, in a prepared statement.
, 百拇医药
Experts also believe that Viread may prove an important option due to its once-a-day dosing regimen.
In clinical trials, Viread reduced the level of circulating HIV by about 75%. The most common side effects included nausea, diarrhea, vomiting and flatulence.
Foster City, California-based Gilead said that the 300 mg tablet should be available within a few days. The company added that it would be indicated for use in combination with other antiretroviral agents for the treatment of previously diagnosed patients.
, 百拇医药
Gilead said that it was conducting additional studies to evaluate Viread in combination with other antiretroviral agents for treatment-naive patients as well as children. The company estimated that about 350,000 Americans presently receive antiretroviral agents, and that another 15,000 patients begin treatment each year.
Earlier this year, Gilead also applied for marketing approval in Europe and Australia. Gilead said that it anticipates the European approval decision to be made in early 2002.
, 百拇医药
On Monday morning, Robertson Stephens analysts Michael King and Dr. Steven Harr raised their sales estimates for Viread, saying that the FDA approval indication was "broader than we expected." The analysts raised their 2002 sales estimates for the drug from $75 million to $125 million and their 2004 estimate from $275 million to $300 million.
In a research note, King and Harr wrote, "We believe [Gilead] will likely target all HIV patients receiving treatment immediately upon launch."
In Monday afternoon trading on the NASDAQ, shares of Gilead slipped 1.62 to 66.06., 百拇医药