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4507 - Shionogi & Co News Story

¥6043 -33.0  -0.5%

Last Trade - 07/08/20

Sector
Healthcare
Size
Large Cap
Market Cap £13.23bn
Enterprise Value £10.73bn
Revenue £2.25bn
Position in Universe 67th / 3862

UPDATE 1-GSK logs win as Health Canada approves its monthly HIV injection

Fri 20th March, 2020 2:27pm
(Adds comment on FDA CRL, details on Health Canada approval)
    March 20 (Reuters) - GlaxoSmithKline's  GSK.L  HIV
treatments division has received approval for its long-acting
HIV injection from Canada's healthcare regulator, in a major win
for the British drugmaker after a U.S. rejection late last year.
   
    GSK's ViiV Healthcare said on Friday that Health Canada had
given the green light to Cabenuva, a monthly injection to
suppress the virus that causes AIDS and is aimed as an
alternative to daily pills. (https://bit.ly/3aatmo8)
    In December, the U.S. Food and Drug Administration (FDA) had
declined to approve the treatment and questioned its chemistry,
manufacturing and controls process, but not its safety in a
complete response letter (CRL).  urn:newsml:reuters.com:*:nL4N28V042
    A GSK spokesperson said on Friday the company was continuing
to work with FDA to address the watchdog's questions.
    ViiV Healthcare, in which Pfizer  PFE.N  and Shionogi
 4507.T  have small stakes, said Health Canada had also approved
Vocabria, an oral tablet to be given along with Cabenuva for a
short time.
    The Canadian approval is the first for the regimen and
bolster GSK's push to using fewer drugs in HIV treatments, as it
looks to boost sales by offering patients a therapy with fewer
potentially toxic side effects.
    Currently, U.S. drugmaker Gilead dominates the HIV market
with its fast-growing Biktarvy.
    The Cabenuva injection contains two active ingredients -
cabotegravir and Janssen's rilpivirine - and has previously
proven as effective as standard daily pills with three active
ingredients when given monthly and also once every two months.
 urn:newsml:reuters.com:*:nFWN20U13N
  

 (Reporting by Pushkala Aripaka in Bengaluru and Ludwig Burger
in Frankfurt;
Editing by Vinay Dwivedi)
 ((Pushkala.A@thomsonreuters.com; Twitter: @pullthekart; Mobile:
+91 852 751 3793))
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