{"id":37064,"date":"2020-01-29T08:45:21","date_gmt":"2020-01-29T08:45:21","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=37064"},"modified":"2020-10-20T14:38:10","modified_gmt":"2020-10-20T14:38:10","slug":"fda-fails-to-approve-long-acting-cabotegravir-rilpivirine-cabenuva-injections-due-to-unspecified-manufacturing-concerns","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/37064","title":{"rendered":"FDA decision on long-acting cabotegravir\/rilpivirine (Cabenuva, Vocabria) injections delayed due to scale-up manufacturing problems"},"content":{"rendered":"

Simon Collins, HIV i-Base<\/span><\/strong><\/p>\n

On 21 December 2019, ViiV Healthcare issued a press release on the recent FDA decision not to approve cabotegravir\/rilpivirine (CAB\/RPV LA) long-acting injections. [1]<\/span><\/strong><\/p>\n

This was unexpected, given that CAB\/RPV LA had successfully completed phase 3 studies (ATLAS and FLAIR), showing high efficacy and low side effects. CAB\/RPV was non-inferior to standard of care combinations in treatment-naive and switch studies and reported improved quality of life compared to oral combinations in study participants.<\/span><\/p>\n

Instead, the FDA has issued a complete response letter relating to chemistry and manufacturing controls (CMC), but the press statement stresses that there are no new safety concerns for these compounds.<\/span><\/p>\n

The letter itself has not been published and specific details about these concerns were not included. <\/span><\/p>\n

Cabotegravir is an integrase inhibitor developed by ViiV Healthcare and rilpivirine is an NNRTI developed by Janssen Sciences. Development of CAB\/RPV long-acting combination is led by ViiV, with the trade name Cabenuva in the US and Vocabria in the EU.<\/p>\n

comment<\/span><\/h3>\n

At a more recent community meeting, the company were more specific that the manufacturing problem was related to scale-up. [2]<\/span><\/strong><\/p>\n

This has been a problem with some earlier HIV meds as large scale production for a marketed drug is very different to smaller productions to just cover research studies.<\/span><\/strong><\/p>\n

ViiV are clear that the company are working with the FDA to resolve these issues. Phase 3 results meant that approval was expected, so this will hopefully be a short delay that can be resolved.<\/span><\/strong><\/p>\n

There has always been high interest in options for HIV treatment other than oral medicines and this announcement is likely to just extend the time a little longer before these become available.<\/span><\/strong><\/p>\n

However, certainly for people in the UK, access will depend on many factors, including cost. <\/span><\/strong><\/p>\n

There are many potential benefits from injectable ART, at least for people who have difficulty with pills, and this will also provide new options for how HIV treatment is delivered.<\/strong><\/p>\n

References<\/span><\/p>\n

    \n
  1. ViiV Healthcare press statement. ViiV Healthcare receives complete response letter from US FDA for use of investigational cabotegravir and rilpivirine long-acting regimen in the treatment of HIV. (21 December 2019).
    \n<\/span>https:\/\/viivhealthcare.com\/en-gb\/media\/press-releases\/2019\/december\/complete-response-letter-from-us-fda<\/span><\/a><\/li>\n
  2. \n

    Personal communication, UK-Community Advisory Board. 24 January 2020.
    \n<\/span>    http:\/\/www.ukcab.net<\/a><\/p>\n<\/li>\n<\/ol>\n

    \u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base On 21 December 2019, ViiV Healthcare issued a press release on the recent FDA decision not to approve cabotegravir\/rilpivirine (CAB\/RPV LA) long-acting injections. [1] This was unexpected, given that CAB\/RPV LA had successfully completed phase 3 …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-37064","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/37064","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\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=37064"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/37064\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=37064"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=37064"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=37064"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}