Amgen公司的 Kineret——类风湿关节炎药物获得Fd
WASHINGTON (Reuters Health) - Amgen said on Wednesday that it has received approval from the US Food and Drug Administration (FDA) to market Kineret (anakinra) for rheumatoid arthritis in adult patients who have failed conventional disease-modifying antirheumatic drugs (DMARDs).
Kineret is the first direct and selective blocker of the protein interleukin-1 (IL-1) to be approved for sale in the US, according to Thousand Oaks, California-based Amgen. The injectable drug is designed to inhibit the inflammatory response associated with rheumatoid arthritis.
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An estimated 2.1 million Americans suffer from rheumatoid arthritis and about 300,000 of those patients don't do well on traditional drugs, Amgen spokesperson Rebecca Hamm told Reuters Health.
Kineret will be priced at $924 for a four-week supply, making it slightly cheaper than American Home Products'/Immunex's Enbrel (etanercept) and Johnson & Johnson's Remicade (infliximab), Hamm said. Both Enbrel and Remicade are TNF-blocking agents.
, 百拇医药
Amgen expects to have Kineret on pharmacy shelves within two weeks and will spread the word of the approval today at the American College of Rheumatology meeting in San Francisco, Hamm said.
She noted that the approval expands Amgen's current line-up to include a whole new disease state, adding that the firm has formed a dedicated sales force to market the drug.
Kineret is indicated to reduce the signs and symptoms of moderately- to severely-active rheumatoid arthritis. It can be used as monotherapy or in combination with DMARDS other than TNF-blocking agents.
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Amgen said the approval was based on clinical trials of a total of 2,932 patients showing that 38% of treatment-group subjects had achieved a 20% improvement in American College of Rheumatology criteria after six months. Only twenty-two percent of placebo-group subjects achieved that level of improvement.
Treatment effects were generally seen by week 13, Amgen noted.
The most common side effects included a mild reaction at the injection site, characterized by redness, swelling and pain. Amgen said there was also a small risk of serious infections, but that most patients can continue receiving the injection after the infection has resolved.
An FDA advisory committee voted six to two with one abstention in August to recommend approval of Kineret. Some committee members were concerned about whether Amgen had established enough efficacy to justify the possible side effects.
In afternoon trading on the NASDAQ, shares of Amgen were down 0.69 at 57.30., 百拇医药
Kineret is the first direct and selective blocker of the protein interleukin-1 (IL-1) to be approved for sale in the US, according to Thousand Oaks, California-based Amgen. The injectable drug is designed to inhibit the inflammatory response associated with rheumatoid arthritis.
, 百拇医药
An estimated 2.1 million Americans suffer from rheumatoid arthritis and about 300,000 of those patients don't do well on traditional drugs, Amgen spokesperson Rebecca Hamm told Reuters Health.
Kineret will be priced at $924 for a four-week supply, making it slightly cheaper than American Home Products'/Immunex's Enbrel (etanercept) and Johnson & Johnson's Remicade (infliximab), Hamm said. Both Enbrel and Remicade are TNF-blocking agents.
, 百拇医药
Amgen expects to have Kineret on pharmacy shelves within two weeks and will spread the word of the approval today at the American College of Rheumatology meeting in San Francisco, Hamm said.
She noted that the approval expands Amgen's current line-up to include a whole new disease state, adding that the firm has formed a dedicated sales force to market the drug.
Kineret is indicated to reduce the signs and symptoms of moderately- to severely-active rheumatoid arthritis. It can be used as monotherapy or in combination with DMARDS other than TNF-blocking agents.
, http://www.100md.com
Amgen said the approval was based on clinical trials of a total of 2,932 patients showing that 38% of treatment-group subjects had achieved a 20% improvement in American College of Rheumatology criteria after six months. Only twenty-two percent of placebo-group subjects achieved that level of improvement.
Treatment effects were generally seen by week 13, Amgen noted.
The most common side effects included a mild reaction at the injection site, characterized by redness, swelling and pain. Amgen said there was also a small risk of serious infections, but that most patients can continue receiving the injection after the infection has resolved.
An FDA advisory committee voted six to two with one abstention in August to recommend approval of Kineret. Some committee members were concerned about whether Amgen had established enough efficacy to justify the possible side effects.
In afternoon trading on the NASDAQ, shares of Amgen were down 0.69 at 57.30., 百拇医药