¿¬±¸µ¿ÇâÁ¤º¸
Á¦¸ñ COVID -19 Ä¡·áÁ¦, ¹ã¶ó´Ïºñ¸¿°ú ¿¡Å×¼¼ºñ¸¿(bamlanivimab & etesevimab) FDA ÀÀ±Þ»ç¿ë½ÂÀÎ
±Û¾´ÀÌ °ü¸®ÀÚ
÷ºÎÆÄÀÏ

 

 

COVID -19 Ä¡·áÁ¦, ¹ã¶ó´Ïºñ¸¿°ú ¿¡Å×¼¼ºñ¸¿(bamlanivimab & etesevimab) FDA ÀÀ±Þ»ç¿ë½ÂÀΠ

 

¹Ì±¹ ½ÄÇ°ÀǾ౹ (FDA)Àº Äڷγª ¹ÙÀÌ·¯½º  (SARS-CoV-2) ´ÜÀÏŬ·ÐÇ×üÀÎ bamlanivimab 700mg °ú etesevimab 1,400mgÀÇ º¹ÇÕ Åõ¿©¸¦  ÁßÁõ ±Þ¼º È£Èí±â ÁõÈıº Ä¡·á¿¡ »ç¿ëÇÒ ¼ö ÀÖµµ·Ï ÀÀ±Þ»ç¿ë ½ÂÀÎ EUA (Emergency Use Authorization)Çß´Ù. 

 

 

 

 

´ë»óÀÚ´Â Äڷγª19 °¨¿°À¸·Î ¿Ü·¡ Ä¡·á¸¦ ¹Þ´Â °æÁõ¿¡¼­ Áߵ ȯÀÚ¿Í,  ÀÔ¿øÀ¸·Î ÁøÇàµÉ ¼ö ÀÖ´Â °íÀ§Ç豺 ÁßÁõ ȯÀÚ¸¦ ´ë»óÀ¸·Î ÁßÁõ È£Èí±â ÁõÈıº Ä¡·áÁ¦·Î  ±ä±Þ »ç¿ëÀ» FDA°¡ ½ÂÀÎÇÑ´Ù.  

 

ÇöÀç±îÁö °¡´ÉÇÑ °ü·Ã ±Ù°ÅÀÚ·á °ËÅä  ÈÄ¿¡  COVID-19 Ä¡·á Áöħ ÆгÎÀº ¾Æ·¡¿Í °°Àº »çÇ×À» °áÁ¤Çß´Ù.

 

EUA ±âÁØ (BIIa)¿¡ Á¤ÀÇ µÈ´ë·Î ÀÓ»ó¿¡¼­ °íÀ§Çè ÁøÇà À§ÇèÀÌ ³ôÀº °æÁõ¿¡¼­ Áߵ COVID-19 °¨¿°ÀÌ µÈ ¿Ü·¡ ȯÀÚ¸¦ À§ÇØ bamlanivimab 700mg°ú etesevimab 1,400mgÀÇ Ä¡·á »ç¿ëÀ» ±ÇÀåÇÑ´Ù.

 

ȯÀÚ°¡ SARS-CoV-2 Ç׿ø ¶Ç´Â ÇÙ»ê ÁõÆø °Ë»ç¿¡¼­ ¾ç¼º °á°ú¸¦ ¹ÞÀº ÈÄ °¡´ÉÇÑ ÇÑ »¡¸® Ä¡·á¸¦ ÇÏ°í Áõ»ó ¹ßº´ ÈÄ 10ÀÏ À̳»¿¡ Ä¡·á¸¦ ½ÃÀÛÇϵµ·Ï ±ÇÀåÇÑ´Ù.

 

½ÂÀÎµÈ Ä¡·á ¿ë·®Àº bamlanivimab 700mg + etesevimab 1,400mgÀ¸·Î  ÀÌ´Â Ä¡·áÁ¦ ½ÂÀÎÀ» µÞ¹ÞħÇÏ´Â µ¥ÀÌÅÍÀÎ ÀÓ»ó 3»ó ¿¬±¸¿¡ Âü¿©ÇÑ  ´ë»óÀڵ鿡°Ô Åõ¿©ÇÑ ¿ë·®º¸´Ù´Â ÀÛÀº ¿ë·®ÀÓÀ» ÁÖ½ÃÇØ¾ß ÇÑ´Ù.

 

½ÂÀÎµÈ ¿ë·®Àº Ç×¹ÙÀÌ·¯½º È°¼ºÀ» º¸¿©ÁÖ´Â µ¥ÀÌÅÍ¿Í ½ÃÇè°ü ³» ¿¬±¸ ¹× ¾àµ¿ÇÐ / ¾à·ÂÇÐÀû ¸ðµ¨¸µ¿¡¼­ ÃßÁ¤µÇ¾ú´Ù.  ÆгÎÀº ÀÓ»ó½ÃÇèÀ» Á¦¿ÜÇÏ°í COVID-19·Î ÀÎÇØ ÀÔ¿øÇÑ È¯ÀÚ¿¡°Ô bamlanivimab 700mg°ú etesevimab 1,400mgÀÇ »ç¿ëÀ» ±ÇÀåÇÏÁö´Â ¾ÊÁö¸¸, COVID-19 ÀÌ¿ÜÀÇ ÀÌÀ¯·Î ÀÔ¿øÇßÁö¸¸ EUA ±âÁØÀ» ÃæÁ·ÇÏ´Â °æÁõ ¶Ç´Â Áߵ COVID-19 ȯÀÚÀÇ °æ¿ì¿¡ µÎ°¡Áö ¾à¹° (bamlanivimab plus etesevimab) ó¹æÀ» °í·ÁÇÒ ¼ö ÀÖ´Ù.

 

Bamlanivimab°ú etesevimabÀÇ Á¦ÇÑµÈ °ø±Þ°¡´É¼º°ú ¾à¹°¹èºÐ ¹× Åõ¿© ¹®Á¦¸¦ °í·ÁÇÒ ¶§ EUA ±âÁØ¿¡ µû¶ó COVID-19 ÁøÇà À§ÇèÀÌ °¡Àå ³ôÀº ȯÀÚ¿¡°Ô ¿ì¼± ¼øÀ§¸¦ ºÎ¿©ÇØ¾ß ÇÑ´Ù.

 

COVID-19ÀÇ ¿µÇâÀ» °¡Àå ¸¹À̹޴ Áö¿ª »çȸ°¡ bamlanivimab°ú etesevimab¿¡ °øÆòÇÏ°Ô Á¢±Ù ÇÒ ¼ö ÀÖµµ·Ï ³ë·ÂÇؾßÇÑ´Ù.

ÀÓ»óÀÇ°¡ º´¿ëÀÇ ÀáÀçÀû ÀÎ ÀÌÁ¡ÀÌ ÀáÀçÀû À§Ç躸´Ù Å©´Ù°í »ý°¢ÇÏ´Â °æ¿ì ÀÓ»óÀÇ°¡ ½É°¢ÇÑ COVID-19·Î ÁøÇàµÉ À§ÇèÀÌ ³ôÀº »óŸ¦ °¡Áø ÀӽźΠ°³Àο¡°Ô´Â ¹ã¶ó´Ïºñ¸¿°ú ¿¡Å×¼¼ºñ¸¿(bamlanivimab & etesevimab)À» Åõ¿©ÇÏÁö ¾Êµµ·Ï ÇÑ´Ù.

 

ÀÔ¿øÇÏÁö ¾Ê¾ÒÁö¸¸ ÁßÁõ ÁúȯÀÇ À§Çè ¿äÀÎÀÌÀÖ´Â COVID-19 ¾Æµ¿À» À§ÇØ bamlanivimab°ú etesevimab ¶Ç´Â ±âŸ ´ÜÀÏ Ç×ü Á¦Ç°ÀÇ »ç¿ëÀ» ±ÇÀåÇϰųª ¹Ý´ë ÇÒ¼ö ÀÖ´Â ¼Ò¾Æ¸¦ ´ë»óÀ¸·Î ÇÑ ÀÚ·á´Â ¾ÆÁ÷±îÁö ÃæºÐÇÏÁö ¾Ê´Ù. ¼ºÀÎÀ» ´ë»óÀ¸·Î ÇÑ ¿¬±¸¿¡ µû¸£¸é bamlanivimab°ú etesevimabÀº EUA ±âÁØÀ» ÃæÁ·ÇÏ´Â ¾î¸°ÀÌ, ƯÈ÷ Çϳª ÀÌ»óÀÇ ±âÁØÀ» ÃæÁ·Çϰųª 16 ¼¼ ÀÌ»óÀÎ ¾î¸°ÀÌÀÇ °æ¿ì »ç·Êº°·Î °í·ÁÇÒ ¼ö ÀÖ´Ù. ÀÌ·¯ÇÑ °æ¿ì¿¡´Â ¼Ò¾Æ  °¨¿°Áõ Àü¹®ÀÇ¿Í »ó´ãÇÏ´Â °ÍÀ» ±ÇÀåÇÑ´Ù. ÀÚ¼¼ÇÑ ³»¿ëÀº ¾Æ·¡ COVID-19 Ä¡·á Áöħ À¥ »çÀÌÆ®¿¡¼­ ã¾Æº¼ ¼ö ÀÖ´Ù. [»ó¼¼º¸±â]

 

[The full statement on the COVID-19 Treatment Guidelines website]

 

References

  1. Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19. News Release. FDA; February 9, 2021. Accessed February 10, 2021. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibodies-treatment-covid-19-0.
  2. Lilly's bamlanivimab (LY-CoV555) administered with etesevimab (LY-CoV016) receives FDA emergency use authorization for COVID-19. News Release. Lilly; February 9, 2021. Accessed February 10, 2021. https://investor.lilly.com/news-releases/news-release-details/lillys-bamlanivimab-ly-cov555-administered-etesevimab-ly-cov016.

2021-02-24 ¿ÀÀü 11:01:29, Á¶È¸¼ö : 2310