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Friday, February 10, 2017 4:15:59 PM
This is kinda interesting:
Looking at the recent NICE document featuring the proposed technology appraisals for 2016 and into 2017, there were and are 81 total appraisals scheduled.
https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guidance/proposed-technology-appraisals#DCVax-L
All of them with the exception of **8** already have a marketing authorization in place. DCVax-L is one of the seven without one.
This link goes into some detail about marketing authorizations in the UK.
https://www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk
The following drugs are the other 7 that were to be appraised without marketing authorizations at the time of appraisal.
You'll notice that most of them (not all of them) receive some sort of approval (FDA, German, European) within a few months of the NICE appraisal.
I’ve indicated the approval status for each and the time they occurred.
Bezlotoxumab for preventing recurrent Clostridium difficile infection
To appraise the clinical and cost effectiveness of bezlotoxumab for preventing recurrent Clostridium difficile infection.
NICE appraisal: 22 November – 20 December 2016
Approval Status/Update: Friday, October 21, 2016 9:57 pm EDT
FDA Approves Merck’s ZINPLAVA™ (bezlotoxumab) to Reduce Recurrence of Clostridium difficile Infection (CDI) in Adult Patients Receiving Antibacterial Drug Treatment for CDI Who Are at High Risk of CDI Recurrence
Approval Status/Update: 1 FEB 2017
Adding bezlotoxumab to standard treatment for C. difficile reduces recurrent infection rate
http://www.pharmaceutical-journal.com/news-and-analysis/news/adding-bezlotoxumab-to-standard-treatment-for-c-difficile-reduces-recurrent-infection-rate/20202267.article
Cytomegalovirus-specific T-cells for preventing and treating cytomegalovirus infection after allogeneic haematopoietic stem cell transplantation
To appraise the clinical and cost effectiveness of cytomegalovirus-specific donor T-cells for preventing and treating cytomegalovirus after allogeneic haematopoietic stem cell transplantation.
NICE appraisal: 21 September – 20 October 2016
Approval Status/Update: 20th October 2016
Merck says drug for CMV in transplant patients hits targets
http://www.pmlive.com/pharma_news/merck_says_drug_for_cmv_in_transplant_patients_hits_targets_1171908
Regorafenib for previously treated unresectable hepatocellular carcinoma
To appraise the clinical and cost effectiveness of regorafenib within its licensed indication for previously treated unresectable hepatocellular carcinoma.
NICE appraisal: 16 August – 13 September 2016
Approval Status/Update: Nov 8, 2016
Bayer seeks approval on
Approval Status/Update: Jan 4, 2017
FDA grants priority review
Eteplirsen for treating Duchenne muscular dystrophy
To evaluate the benefits and costs of eteplirsen within its licensed indication for treating of Duchenne muscular dystrophy for national commissioning by NHS England.
NICE appraisal: 28 July – 25 August 2016
Approval Status/Update: September 19, 2016
FDA grants accelerated approval to first drug for Duchenne muscular dystrophy
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm521263.htm
Masitinib for treating the amyotrophic lateral sclerosis form of motor neurone disease
AB Science Announces Positive Interim Results from Phase 3 Trial of Masitinib in Amyotrophic Lateral Sclerosis (ALS)
NICE appraisal: 1 June – 29 June 2016
Approval Status/Update: JANUARY 5, 2017
Anti-Inflammation Treatment Masitinib Protects Against ALS Damage Researchers Say
https://alsnewstoday.com/2017/01/05/masitinib-protects-muscles-and-nerves-from-amyotrophic-lateral-sclerosis-damage/
Venetoclax for treating chronic lymphocytic leukaemia associated with a 17p deletion or TP53 mutation
NICE appraisal: 12 February – 11 March 2016
Approval Status/Update: December 8, 2016
European Commission Grants Conditional Marketing Approval for AbbVie's VENCLYXTO™ (venetoclax) Monotherapy for Appropriate Patients with Difficult-To-Treat Chronic Lymphocytic Leukaemia
Dimethyl fumarate for treating moderate to severe plaque psoriasis
NICE appraisal: 29 January – 26 February 2016
Approval Status/Update: November 15, 2016
Efficacy and safety of LAS41008 (dimethyl fumarate) in adults with moderate-to-severe chronic plaque psoriasis: a randomized, double-blind, Fumaderm®- and placebo-controlled trial (BRIDGE)
http://onlinelibrary.wiley.com/doi/10.1111/bjd.14947/full
Looking at the recent NICE document featuring the proposed technology appraisals for 2016 and into 2017, there were and are 81 total appraisals scheduled.
https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guidance/proposed-technology-appraisals#DCVax-L
All of them with the exception of **8** already have a marketing authorization in place. DCVax-L is one of the seven without one.
This link goes into some detail about marketing authorizations in the UK.
https://www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk
The following drugs are the other 7 that were to be appraised without marketing authorizations at the time of appraisal.
You'll notice that most of them (not all of them) receive some sort of approval (FDA, German, European) within a few months of the NICE appraisal.
I’ve indicated the approval status for each and the time they occurred.
Bezlotoxumab for preventing recurrent Clostridium difficile infection
To appraise the clinical and cost effectiveness of bezlotoxumab for preventing recurrent Clostridium difficile infection.
NICE appraisal: 22 November – 20 December 2016
Approval Status/Update: Friday, October 21, 2016 9:57 pm EDT
FDA Approves Merck’s ZINPLAVA™ (bezlotoxumab) to Reduce Recurrence of Clostridium difficile Infection (CDI) in Adult Patients Receiving Antibacterial Drug Treatment for CDI Who Are at High Risk of CDI Recurrence
Approval Status/Update: 1 FEB 2017
Adding bezlotoxumab to standard treatment for C. difficile reduces recurrent infection rate
http://www.pharmaceutical-journal.com/news-and-analysis/news/adding-bezlotoxumab-to-standard-treatment-for-c-difficile-reduces-recurrent-infection-rate/20202267.article
Cytomegalovirus-specific T-cells for preventing and treating cytomegalovirus infection after allogeneic haematopoietic stem cell transplantation
To appraise the clinical and cost effectiveness of cytomegalovirus-specific donor T-cells for preventing and treating cytomegalovirus after allogeneic haematopoietic stem cell transplantation.
NICE appraisal: 21 September – 20 October 2016
Approval Status/Update: 20th October 2016
Merck says drug for CMV in transplant patients hits targets
http://www.pmlive.com/pharma_news/merck_says_drug_for_cmv_in_transplant_patients_hits_targets_1171908
Regorafenib for previously treated unresectable hepatocellular carcinoma
To appraise the clinical and cost effectiveness of regorafenib within its licensed indication for previously treated unresectable hepatocellular carcinoma.
NICE appraisal: 16 August – 13 September 2016
Approval Status/Update: Nov 8, 2016
Bayer seeks approval on
Approval Status/Update: Jan 4, 2017
FDA grants priority review
Eteplirsen for treating Duchenne muscular dystrophy
To evaluate the benefits and costs of eteplirsen within its licensed indication for treating of Duchenne muscular dystrophy for national commissioning by NHS England.
NICE appraisal: 28 July – 25 August 2016
Approval Status/Update: September 19, 2016
FDA grants accelerated approval to first drug for Duchenne muscular dystrophy
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm521263.htm
Masitinib for treating the amyotrophic lateral sclerosis form of motor neurone disease
AB Science Announces Positive Interim Results from Phase 3 Trial of Masitinib in Amyotrophic Lateral Sclerosis (ALS)
NICE appraisal: 1 June – 29 June 2016
Approval Status/Update: JANUARY 5, 2017
Anti-Inflammation Treatment Masitinib Protects Against ALS Damage Researchers Say
https://alsnewstoday.com/2017/01/05/masitinib-protects-muscles-and-nerves-from-amyotrophic-lateral-sclerosis-damage/
Venetoclax for treating chronic lymphocytic leukaemia associated with a 17p deletion or TP53 mutation
NICE appraisal: 12 February – 11 March 2016
Approval Status/Update: December 8, 2016
European Commission Grants Conditional Marketing Approval for AbbVie's VENCLYXTO™ (venetoclax) Monotherapy for Appropriate Patients with Difficult-To-Treat Chronic Lymphocytic Leukaemia
Dimethyl fumarate for treating moderate to severe plaque psoriasis
NICE appraisal: 29 January – 26 February 2016
Approval Status/Update: November 15, 2016
Efficacy and safety of LAS41008 (dimethyl fumarate) in adults with moderate-to-severe chronic plaque psoriasis: a randomized, double-blind, Fumaderm®- and placebo-controlled trial (BRIDGE)
http://onlinelibrary.wiley.com/doi/10.1111/bjd.14947/full
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