{"id":2929,"date":"2006-10-07T10:48:10","date_gmt":"2006-10-07T09:48:10","guid":{"rendered":"http:\/\/moomango.co.uk\/htb\/?p=2929"},"modified":"2013-12-06T16:02:33","modified_gmt":"2013-12-06T16:02:33","slug":"fda-decision-delayed-on-biojector-for-administering-t-20-pending-additional-safety-information","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/2929","title":{"rendered":"FDA decision delayed on Biojector for administering T-20 pending additional safety information"},"content":{"rendered":"<p><strong>Simon Collins, HIV i-Base<\/strong><\/p>\n<p><strong>On 12 October, Roche issued a press release relating to the timeline for the FDA decision on the Biojector 2000 system that is currently being studied in an open label expanded access trial in the US.<\/strong><\/p>\n<p>Several small studied reported that many patients found this needle-free device, which fires T-20 through the skin under pressure, reduced the severity of injection site reactions, and improved quality of life.<\/p>\n<p>In the larger safety study, a small proportion of patients have experienced haemotoma and nerve damage, largely relating to when the device has been used in site with earlier scar tissue or near bone &#8211; both of which are not recommended as injection sites in the prescribing information for T-20.<\/p>\n<p>Collecting additional data on these events will probably delay the FDA decision until early 2007.<\/p>\n<p>It is expected that this will have a similar effect on regulatory decisions in Europe. Currently, unless they have been able to purchase this privately in the US, UK patients do not have access to the Biojector.<\/p>\n<p>Source: Roche press release (12 October, 2006)<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Simon Collins, HIV i-Base On 12 October, Roche issued a press release relating to the timeline for the FDA decision on the Biojector 2000 system that is currently being studied in an open label expanded access trial in the US. &hellip;<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-2929","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/2929","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=2929"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/2929\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=2929"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=2929"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=2929"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}