Mar 22 · UK launch is reported to have actually happened in Nov 21 (not Jul 21 as previously stated) [28].
Feb 22 · UK price for 2 x 40mg film coated tablets = £100.00. Dose is 80mg as a single dose, taken within 2 days of onset of symptoms or 40mg as a single dose if patient weight <80kg [27].
Jul 21 · Launched in the UK [26].
Jul 21 · MHRA publishes SPC for baloxavir, which is licensed in the UK for treatment of uncomplicated influenza and post-exposure prophylaxis of influenza in individuals aged 12 years and above. The SPC indicates approval actually happened in Jun 21, although information from the company previously indicated it happened in Jan 21 [25].
May 21 · UK launch planned for July 2021 [24].
Jan 21 · Approved in UK [23].
Jan 21 · Licensed in EU (not UK) [22].
Nov 20 · Recommended for EU approval by CHMP - the full indication is "for the treatment of uncomplicated influenza in patients aged 12 years and above. Also: for post-exposure prophylaxis of influenza in individuals aged 12 years and above." It should be used in accordance with official recommendations [21].
Dec 19 · NDA is for indication ´treatment of influenza in patients aged 12 and above, including patients at high risk of developing influenza-related complications and for post-exposure prophylaxis of influenza in individuals aged 12´ [19].
Dec 19 · The EMA have received a centralised marketing authorisation application for baloxavir. [16]
Feb 19 · Uptake has been slow since launch in the US, partly due to its high cost, but also due to fears about resistance, with reports of ´mutant´ viral flu strains affecting efficacy of baloxavir in Japan [15].
Oct 18 · EU filing planned for 2019 [14].
Oct 18 · Approved in the US for the treatment of acute uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours [13]
Jun 18 · Filed in US under priority review [7]
Feb 18 · EU & US filings planned for 2018 [6].
Sep 17 · Based on the results from CAPSTONE-1, a New Drug Application is planned in Japan later this year, as is a submission to US FDA [4].
Jun 16 · Originated by Shionogi in Japan and licensed to Roche worldwide except Japan and Taiwan; Shionogi have it in PII trials in Japan and project a Japanese launch by Q1 2018 [1].