Our latest Investing Matters Podcast episode with QuotedData's Edward Marten has just been released. Listen here.

Less Ads, More Data, More Tools Register for FREE

Pin to quick picksGlaxosmithkline Regulatory News (GSK)

Share Price Information for Glaxosmithkline (GSK)

London Stock Exchange
Share Price is delayed by 15 minutes
Get Live Data
Share Price: 1,705.60
Bid: 1,705.40
Ask: 1,705.80
Change: 0.40 (0.02%)
Spread: 0.40 (0.023%)
Open: 1,701.60
High: 1,709.60
Low: 1,699.40
Prev. Close: 1,705.20
GSK Live PriceLast checked at -

Watchlists are a member only feature

Login to your account

Alerts are a premium feature

Login to your account

GSK receives CRL from FDA for mepolizumab in COPD

10 Sep 2018 07:00

RNS Number : 1960A
GlaxoSmithKline PLC
07 September 2018
 

Issued: 7 September 2018, London UK - LSE Announcement

 

GSK receives complete response letter from US FDA for use of mepolizumab in COPD patients

 

 

 

 

GlaxoSmithKline plc (LSE/NYSE: GSK) today received a complete response letter (CRL) from the US FDA regarding its application for mepolizumab as an add-on treatment to inhaled corticosteroid-based maintenance treatment for the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD), guided by blood eosinophil counts.

 

The CRL states that more clinical data are required to support an approval. GSK will work closely with the FDA to determine the appropriate next steps for the supplementary biologics licence application (sBLA).

 

About mepolizumab

First approved in 2015 for severe eosinophilic asthma, and also licenced for EGPA in the US, mepolizumab is the first-in-class monoclonal antibody that targets IL-5. It is believed to work by preventing IL-5 from binding to its receptor on the surface of eosinophils. Inhibiting IL-5 binding in this way reduces blood eosinophils.

Mepolizumab has been studied in over 3000 patients in 16 clinical trials across a number of eosinophilic indications and is currently being investigated for severe hypereosinophilic syndrome and nasal polyposis, in addition to the sBLA filed for the treatment of patients with COPD.

 

GSK in respiratory disease

GSK has led the way in developing innovative medicines to advance the management of asthma and COPD for nearly 50 years. Over the last five years we have launched six innovative medicines responding to continued unmet patient need, despite existing therapies. This is an industry-leading portfolio in breadth, depth and innovation, developed to reach the right patients, with the right treatment.

 

GSK - a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com. 

 

Trademarks are owned by or licensed to the GSK group of companies.

 

 

GSK enquiries:

 

 

 

UK Media enquiries:

Simon Steel

+44 (0) 20 8047 5502

(London)

 

 

 

 

US Media enquiries:

Karen Hagens

+1 919 483 2863

(North Carolina)

 

Anna Padula

+1 215 760 2928

(Philadelphia)

 

 

 

 

Analyst/Investor enquiries:

Sarah Elton-Farr

+44 (0) 20 8047 5194

(London)

 

James Dodwell

+44 (0) 20 8047 2406

(London)

 

Danielle Smith

+44 (0) 20 8047 7562

(London)

 

Jeff McLaughlin

+1 215 751 7002

(Philadelphia)

 

 

 

 

 

 

 

Cautionary statement regarding forward-looking statementsGSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D Principal risks and uncertainties in the company's Annual Report on Form 20-F for 2017.

 

 

Registered in England & Wales:

No. 3888792

 

Registered Office:

980 Great West Road

Brentford, Middlesex

TW8 9GS

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.
 
END
 
 
REAUGUQWBUPRPUM
Date   Source Headline
26th Mar 20243:30 pmRNSDirector/PDMR Shareholding
25th Mar 20241:00 pmRNSNotice of AGM
22nd Mar 20244:20 pmRNSTransfer of Treasury Shares
22nd Mar 20243:36 pmRNSDirector/PDMR Shareholding
18th Mar 20249:30 amRNSNew Phase III Jemperli data in endometrial cancer
13th Mar 20243:48 pmRNSDirector/PDMR Shareholding
8th Mar 20245:12 pmRNSBoard Committee Change
7th Mar 20247:00 amRNSGSK announces positive Blenrep DREAMM-8 results
6th Mar 20244:00 pmRNSViiV LAI vs oral SOC data in adherence-challenged
5th Mar 20245:24 pmRNSGSK Annual Report 2023 on Form 20-F
5th Mar 20247:00 amRNSNew ViiV LA formulation potential 4-month dosing
1st Mar 20243:00 pmRNSTotal Voting Rights
1st Mar 202412:15 pmRNSGSK publishes Annual Report 2023
29th Feb 20247:05 amRNSDirectorate Change
29th Feb 20247:00 amRNSStatement: Zantac (ranitidine) litigation
26th Feb 20243:30 pmRNSDirector/PDMR Shareholding
26th Feb 20247:00 amRNSGSK announces positive EAGLE-1 headline results
22nd Feb 20243:30 pmRNSDirector/PDMR Shareholding
21st Feb 20247:00 amRNSViiV LAI superior to orals in adherence-challenged
20th Feb 20249:01 amRNSJulie Brown - External Appointment
19th Feb 20243:30 pmRNSDirector/PDMR Shareholding
15th Feb 20243:32 pmRNSDirector/PDMR Shareholding
15th Feb 20247:00 amRNSGSK completes acquisition of Aiolos Bio
13th Feb 20244:45 pmRNSDirector/PDMR Shareholding - Replacement
13th Feb 20243:40 pmRNSDirector/PDMR Shareholding
13th Feb 20243:35 pmRNSDirector/PDMR Shareholding
13th Feb 20243:30 pmRNSDirector/PDMR Shareholding
6th Feb 20247:10 amRNSFDA accepts Arexvy filing for adults 50-59 at risk
6th Feb 20247:05 amRNSShingrix 18+ at risk China filing review accepted
6th Feb 20247:00 amRNSGSK presents positive DREAMM-7 phase III data
1st Feb 20243:30 pmRNSDirector/PDMR Shareholding
1st Feb 20243:00 pmRNSTotal Voting Rights
1st Feb 20247:00 amRNSStatement: Zantac (ranitidine) litigation
31st Jan 20247:00 amRNSFinal Results
29th Jan 20247:05 amRNSEMA accepts Arexvy filing for adults 50-59 at risk
29th Jan 20247:00 amRNSEuropean Commission authorises Omjjara in the EU
19th Jan 20243:30 pmRNSDirector/PDMR Shareholding
18th Jan 20245:00 pmRNSHolding(s) in Company
17th Jan 20243:30 pmRNSDirector/PDMR Shareholding
17th Jan 20247:00 amRNSGSK completes sale of shares in Haleon plc
16th Jan 20244:40 pmRNSGSK announces intention to sell shares in Haleon
16th Jan 20243:30 pmRNSDirector/PDMR Shareholding
10th Jan 20247:00 amRNSNucala approved in China for use in severe asthma
9th Jan 20247:00 amRNSGSK enters agreement to acquire Aiolos Bio
2nd Jan 20243:00 pmRNSTotal Voting Rights
21st Dec 20233:30 pmRNSDirector/PDMR Shareholding
20th Dec 20234:44 pmRNSPublication of EMTN Suppl.Prospcts
18th Dec 20237:00 amRNSJemperli plus Zejula Trial Meets Endpoint
13th Dec 20233:30 pmRNSDirector/PDMR Shareholding
12th Dec 20237:00 amRNSJapan accepts Arexvy filing for at risk adults

Due to London Stock Exchange licensing terms, we stipulate that you must be a private investor. We apologise for the inconvenience.

To access our Live RNS you must confirm you are a private investor by using the button below.

Login to your account

Don't have an account? Click here to register.

Quickpicks are a member only feature

Login to your account

Don't have an account? Click here to register.