US regulators OK once-monthly MS shot

A board to discuss future MS therapies in early stage (Phase I or II) trials.

US regulators OK once-monthly MS shot

Postby NHE » Tue May 31, 2016 2:26 am

It seems that daclizumab may be coming to a neurologist near you. Beware!

US regulators OK once-monthly MS shot.
http://www.pharmatimes.com/news/us_regu ... ot_1032347

US patients with multiple sclerosis could soon gain access to a new treatment option after the US Food and Drug Administration approved Biogen and AbbVie's once-monthly, self-administered subcutaneous injection Zinbryta.

.............................................................................................

The boxed warning informs prescribers that the drug can cause severe liver injury, including life-threatening and fatal events, and also highlights other important risks of treatment including immune conditions, such as inflammation of the colon, skin reactions, and enlargement of lymph nodes.

Additional highlighted warnings include hypersensitivity reactions (anaphylaxis or angioedema), increased risk of infections, and symptoms of depression and/or suicidal ideation.
User avatar
NHE
Volunteer Moderator
 
Posts: 4237
Joined: Sat Nov 20, 2004 3:00 pm

Advertisement

Re: US regulators OK once-monthly MS shot

Postby ElliotB » Tue May 31, 2016 8:54 am

"the drug can cause severe liver injury, including life-threatening and fatal events"

How do drugs like this ever get approved in the first place?
ElliotB
Family Elder
 
Posts: 986
Joined: Mon Feb 03, 2014 4:08 pm

Re: US regulators OK once-monthly MS shot

Postby NHE » Thu Jun 02, 2016 9:55 pm

ElliotB wrote: "the drug can cause severe liver injury, including life-threatening and fatal events"

How do drugs like this ever get approved in the first place?

It seems like "first do no harm" has fallen to the double edged sword of money and greed.
User avatar
NHE
Volunteer Moderator
 
Posts: 4237
Joined: Sat Nov 20, 2004 3:00 pm


Return to Drug Pipeline

 


  • Related topics
    Replies
    Views
    Last post

Who is online

Users browsing this forum: No registered users


Contact us | Terms of Service