Thursday, June 28, 2018

PRO/EDR> Influenza (19): WHO global update, new drug

INFLUENZA (19): WHO GLOBAL UPDATE, NEW DRUG
*******************************************
A ProMED-mail post
<http://www.promedmail.org>
ProMED-mail is a program of the
International Society for Infectious Diseases
<http://www.isid.org>

[1] WHO global update
Date: Mon 25 Jun 2018
Source: WHO Surveillance and monitoring, influenza updates [edited]
<http://www.who.int/influenza/surveillance_monitoring/updates/latest_update_GIP_surveillance/en/>


Influenza update - 318 (based on data up to 10 Jun 2018)
--------------------------------------------------------

Information in this report is categorized by influenza transmission
zones, which are geographical groups of countries, areas or
territories with similar influenza transmission patterns.

Summary
-------
Influenza detections continued to increase in recent weeks in Southern
Africa, however influenza activity remained under seasonal thresholds
in most of the other countries of the temperate zone of the southern
hemisphere. In the temperate zone of the northern hemisphere influenza
activity returned to inter-seasonal levels. Increased influenza
activity was reported in some countries of tropical America.
Worldwide, seasonal influenza subtype A viruses accounted for the
majority of detections.

National Influenza Centres (NICs) and other national influenza
laboratories from 71 countries, areas or territories reported data to
FluNet for the time period from 28 May 2018 to 10 Jun 2018 (data as of
21 Jun 2018 12:36:57 UTC). The WHO GISRS laboratories tested more than
52 268 specimens during that time period. 1106 were positive for
influenza viruses, of which 786 (71.1 percent) were typed as influenza
A and 320 (28.9 percent) as influenza B. Of the sub-typed influenza A
viruses, 461 (72.8 percent) were influenza A(H1N1)pdm09 and 172 (27.2
percent) were influenza A(H3N2). Of the characterized B viruses, 77
(74 percent) belonged to the B-Yamagata lineage and 27 (26 percent) to
the B-Victoria lineage.

--
Communicated by:
ProMED-mail from HealthMap Alerts
<promed@promedmail.org>

------
[2] New Drug
Date: Wed 27 Jun 2017
Source: Stat News [edited]
<https://www.statnews.com/2018/06/27/flu-drug-single-pill/>


Next winter, there may be a new drug for people who contract
influenza- one that appears to be able to shut down infection quickly
and, unlike anything else on the market, can be taken as a single
dose.

The Food and Drug Administration on [Tue 26 Jun 2018] said that it
would give the drug, baloxavir marboxil, a priority review, and
approval has the potential to upend the way influenza is treated.

Baloxavir marboxil has already been licensed in Japan, where it is
sold by Shionogi & Co. under the brand name Xofluza. Roche bought most
of the global rights to the drugs -- Shionogi retains the rights in
Japan and Taiwan -- and Genentech, a Roche company, is developing the
drug for the U.S. market. The FDA has told Genentech that it will
issue a decision on baloxavir marboxil within 6 months -- in other
words, before Christmas.

The drug has been shown to reduce the duration of flu symptoms by a
little more than a day -- most uncomplicated flu infections only last
a few days -- and reduce the duration of fever by nearly a day. It
also substantially cut the length of time people sick with influenza
were coughing and sneezing out viruses -- a potential benefit for the
people around those sick individuals.

A single-dose drug that is potent and fast-acting is significant. Any
time you can make a drug easier to take, the chances that people will
actually take it, and take it properly, go up. Public health
authorities actually think flu drugs are underutilized, so a drug that
works well and has more appeal to doctors and patients would be an
advance. The other flu drug people might know about, Tamiflu, is given
as 2 pills a day for 5 days.

Secondly, this drug works differently from all the other -- and there
aren't that many other -- flu drugs on the market. It is an
endonuclease inhibitor; this is the first new class of influenza drugs
to hit the market in over 2 decades. There are only 2 other classes of
flu drugs, neuraminidase inhibitors (drugs like Tamiflu, Relenza,
Rapivab) and the adamantane drugs (amantadine and rimantadine). The
latter class is not recommended for use because flu viruses quickly
develop resistance to them.

New drug classes are always a welcome development because they provide
a hedge if flu viruses develop resistance to existing drugs. "Just
relying on essentially one class of drug for something that can have
the public health impact that influenza can have is crazy," said
Richard Webby, head of the World Health Organization's influenza
collaborating center at St. Jude Children's Research Hospital in
Memphis. "So I think the more compounds we can have, the better."

Another class of flu drugs also opens up the possibility of using
drugs in combination to reduce the risk that viruses will develop
resistance to the drugs, said Webby, who has studied another
experimental drug in this class but is not involved in bringing
baloxavir marboxil to market.
How it works
------------
The drug interferes with a key step in the flu infection process. Flu
viruses invade the cells in the human respiratory tract and use those
cells as mini factories to pump out swarms of copies of themselves
that then break out of those cells to infect others.

Mark Eisner, Genentech's vice president of product development for
immunology, infectious diseases, and ophthalmology, said the clinical
trial used to prove the drug worked enrolled subjects 12 years of age
and older. So it's likely if the FDA approves the drug, it will be
approved for the same patient population.

Additional studies will be done to test the drug's safety and
effectiveness in younger children. Others will test to see if the drug
benefits people who are hospitalized with severe influenza
infections.

When it will hit the market
---------------------------
If the FDA approves baloxavir marboxil, will it be available next flu
season? Maybe. "We are working very hard to make it available as soon
as possible after approval. And we will work with the FDA to do
everything we can to expedite [availability]," Eisner said.

The big unknown
---------------
The price set for this drug will be crucial. How much are people
willing to spend to cut a day or so off of a bout of flu? Genentech
said it's too early to comment on what the cost of the drug might be.
In Japan, the drug sells for the equivalent of about 43.5 USD.

A related unknown
-----------------
Tamiflu and the other drugs in its class never got the market
acceptance in the U.S. that their manufacturers hoped and public
health authorities expected them to get.

The reason: There has been a perception that the benefits -- a little
less time in bed -- don't justify trying to get a doctor's
appointment, get to the doctor's office, and then find a pharmacy with
the drug in stock. Many doctors also are underwhelmed by the drugs,
and aren't inclined to prescribe them.

Then there is the issue of the treatment window. Neuraminidase
inhibitors work best if treatment starts within 48 hours of symptom
onset. After that, in cases of uncomplicated flu, you're into the
realm of diminishing returns given that most patients' symptoms will
begin to dissipate on their own. Baloxavir marboxil also needs to be
taken within that 48-hour window -- or at least that's what is known
about the drug now, Eisner said.

The question for the new drug will be: Does the prospect of a
fast-acting, one-dose treatment override skepticism over flu drugs?
Webby said it's possible the "one-and-done" nature of the drug could
increase usage.

[Byline: Helen Branswell]

--
Communicated by:
ProMED-mail from HealthMap Alerts
<promed@promedmail.org>

[Baloxavir marboxil is an influenza therapeutic agent (cap-dependent
endonuclease inhibitor), characterized by being a single dose. It was
approved for sale in Japan on 23 Feb 2018 (1). In June 2018, the FDA
granted priority review and is expected to make a decision on approval
by December 2018.

Unlike neuraminidase inhibitors such as oseltamivir (Tamiflu) and
zanamivir (Relenza) that inhibit the action of neuraminidase, which
liberates viruses from the infected cells surface, baloxavir marboxil
may prevent replication by inhibiting the cap-dependent endonuclease
activity of the viral polymerase (2). It achieves this by inhibiting
the process known as cap snatching, which is a mechanism exploited by
viruses to hijack the host mRNA transcription system to allow
synthesis of viral RNAs.

The new drug from another class presents a unique alternative to the
currently available limited options for influenza treatment and since
the clinical trials in Japan already permitted its prescription in
there, its availability on a global scale after necessary clearance
can be helpful in reducing influenza associated morbidity and
mortality. - Mod.UBA

References:
1.- "XOFLUZA (Baloxavir Marboxil) Tablets 10mg/20mg Approved For The
Treatment Of Influenza Types A And B In Japan". 23 Feb 2018 - via
<www.publicnow.com>.
2.- Dias A, Bouvier D, Crépin T, et al. The cap-snatching
endonuclease of influenza virus polymerase resides in the PA subunit.
Nature. 458 (7240): 914-918. doi:10.1038/nature07745. Abstract
available at:
<https://www.nature.com/articles/nature07745>]

[See Also:
Influenza (18): WHO global update, Maldives
http://promedmail.org/post/20180602.5827327
Influenza (17): India, Australia
http://promedmail.org/post/20180524.5813105
Influenza (16): Honduras, seasonal
http://promedmail.org/post/20180522.5807724
Influenza (15): WHO global update, Brazil
http://promedmail.org/post/20180517.5798872
Influenza (14): WHO global update
http://promedmail.org/post/20180419.5754241
Influenza (13): WHO global update
http://promedmail.org/post/20180407.5728024
Influenza (12): USA, seasonal, 2nd wave influenza B
http://promedmail.org/post/20180329.5717195
Influenza (11): Netherlands, seasonal reassortant A(H1N2) identified
http://promedmail.org/post/20180322.5702553
Influenza (10): WHO global update, Kenya
http://promedmail.org/post/20180310.5672765
Influenza (09): WHO global update, vaccine recommendations
http://promedmail.org/post/20180225.5644013
Influenza (08): Nepal (Kathmandu) post influenza cough, type B
association susp. http://promedmail.org/post/20180220.5636924
Influenza (07): seasonal, H1N1, research
http://promedmail.org/post/20180215.5627287
Influenza (06): WHO global update, universal vaccine
http://promedmail.org/post/20180208.5610688
Influenza (05): seasonal, multiple locations
http://promedmail.org/post/20180121.5570116
Influenza (04): WHO global update, multiple locations, preparedness
http://promedmail.org/post/20180113.5557168
Influenza (03): Asia (Pakistan, Nepal)
http://promedmail.org/post/20180111.5551430
Influenza (02): increased seasonal activity, USA, Europe, Asia
http://promedmail.org/post/20180104.5534440
Influenza (01): Pakistan (PB) H1N1
http://promedmail.org/post/20180101.5531217
2017
----
Influenza (35): WHO global update, USA, Canada, research agenda,
treatment http://promedmail.org/post/20171227.5521739
Influenza (34): WHO global update
http://promedmail.org/post/20171129.5472374
Influenza (33): WHO global update
http://promedmail.org/post/20171117.5446933
Influenza (32): swine origin, human-animal interface, WHO
http://promedmail.org/post/20171115.5445138
Influenza (31): USA (NE), swine origin, H3N2v
http://promedmail.org/post/20171107.5426321
Influenza (30): India, H1N1
http://promedmail.org/post/20171027.5404830
Influenza (20): USA (ND) swine origin H3N2v
http://promedmail.org/post/20170818.5254537
Influenza (10): WHO global update
http://promedmail.org/post/20170413.4962706
Influenza (05): WHO global update
http://promedmail.org/post/20170214.4837368
Influenza (04): Italy, H1N1, indirect exp to swine
http://promedmail.org/post/20170203.4812459
Influenza (03): WHO global update
http://promedmail.org/post/20170126.4792948
Influenza (02): WHO global update, national reports
http://promedmail.org/post/20170116.4767472
Influenza (01): Canada, H3N2v
http://promedmail.org/post/20170102.4731669
2016
----
Influenza (51): WHO global update, seasonal, country reports
http://promedmail.org/post/20161228.4727494
Influenza (50): WHO Global update, Costa Rica, seasonal
http://promedmail.org/post/20161217.4691931
Influenza (40): Mexico (AG) seasonal surge
http://promedmail.org/post/20161014.4559640
Influenza (30): WHO global update, seasonal
http://promedmail.org/post/20160726.4370090
Influenza (20): seasonal, WHO global update
http://promedmail.org/post/20160421.4173579
Influenza (10): WHO update, risk assessment, Ukraine, E Europe, Middle
East H1N1 http://promedmail.org/post/20160210.4007591
Influenza (01): India (MH) H1N1
http://promedmail.org/post/20160103.3907597
and other items in the archives]
.................................................uba/ao/dk
*##########################################################*
************************************************************
ProMED-mail makes every effort to verify the reports that
are posted, but the accuracy and completeness of the
information, and of any statements or opinions based
thereon, are not guaranteed. The reader assumes all risks in
using information posted or archived by ProMED-mail. ISID
and its associated service providers shall not be held
responsible for errors or omissions or held liable for any
damages incurred as a result of use or reliance upon posted
or archived material.
************************************************************
Donate to ProMED-mail. Details available at:
<http://www.isid.org/donate/>
************************************************************
Visit ProMED-mail's web site at <http://www.promedmail.org>.
Send all items for posting to: promed@promedmail.org (NOT to
an individual moderator). If you do not give your full name
name and affiliation, it may not be posted. You may unsub-
scribe at <http://ww4.isid.org/promedmail/subscribe.php>.
For assistance from a human being, send mail to:
<postmaster@promedmail.org>.
############################################################
############################################################

List-Unsubscribe: http://ww4.isid.org/promedmail/subscribe.php

0 comments:

Post a Comment