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Friday 24 May 2019
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Topic: Dermatology

July 5, 2018
Cimzia can be used for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy, following label extension by European Medicines Agency (EMA)

The European Medicines Agency (EMA) has approved a label extension for Cimzia (certolizumab pegol) therapy, Belgian biopharmaceutical company UCB has announced.
 
The extension allows Cimzia’s use for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
 

May 17, 2018
Public health scheme aims to improve awareness of atopic dermatitis

A scheme to raise awareness about the emotional and physical impact of the most common type of eczema has been launched by a leading charity and a global biopharmaceutical company this month.

 

May 4, 2018
<p>The NICE decision will result in quicker access for patients to the first selective<br /> IL-23 inhibitor</p>

The Janssen Pharmaceutical Companies of Johnson & Johnson has announced that the UK’s National Institute for Health and Care Excellence (NICE) has issued its Final Appraisal Determination (FAD) recommending Tremfya® (guselkumab) for treatment of adults with moderate to severe plaque psoriasis.1
 

The NICE recommendation states that guselkumab is recommended as an option for treating plaque psoriasis in adults, only if:

April 6, 2018
<p>The health body felt there was uncertainty about cost-effectiveness estimates for this treatment of atopic dermatitis</p>

The National Institute for Health and Care Excellence (NICE) has issued draft guidance that does not recommend Dupixent® (dupilumab), within its marketing authorisation, for the treatment of moderate-to-severe atopic dermatitis in adults when systemic therapy is suitable.

 

March 9, 2018
Xolair is the only licensed treatment option for chronic spontaneous urticaria, for patients unresponsive to antihistamines and the guideline aims to achieve complete symptom control of patients

A new global guideline on chronic urticaria (CU) recommends Xolair® (omalizumab), indicated as add-on therapy for the treatment of chronic spontaneous urticaria (CSU), for patients who are not responding to antihistamines.1,2

 

Xolair is the only licensed treatment option for CSU, a type of CU, for patients unresponsive to antihistamines.1

 

February 19, 2018
New data from VOYAGE 2 trial shows high efficacy response rates were achieved with continuous guselkumab treatment versus withdrawal

The Janssen Pharmaceutical Companies of Johnson & Johnson has announced new data that showed a vast majority of patients with moderate to severe plaque psoriasis receiving Tremfya® (guselkumab), who achieved at least a 90% improvement in the Psoriasis Area and Severity Index (PASI 90) at week 28, maintained a PASI 90 response with continuous treatment through week 72.1

 

February 13, 2018
Draft NICE guidance paves the way for access to treatment with brodalumab on the National Health Service

LEO Pharma welcomes the news that the National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination (FAD) recommending the use of brodalumab 210mg for the treatment of adult patients with severe plaque psoriasis, as defined by a total Psoriasis Area and Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10, who have not responded to standard systemic therapies or who are unable to take them.1

 

February 9, 2018
Dupilumab is a monoclonal antibody that has been recently licensed for the management of adults with moderate to severe eczema that is unresponsive to topical therapy
The term ‘atopy’ describes a genetic predisposition to develop allergic symptoms that affect the skin, gut, sinuses and airways. Typically, cutaneous symptoms develop first, followed by food allergies, allergic rhinitis and finally asthma in what is described as the ‘atopic march’.1
 
January 23, 2018
Ixekizumab is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor

Eli Lilly and Company has announced that the European Commission has granted marketing authorisation (MA) for Taltz® (ixekizumab), alone or in combination with methotrexate, for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying anti-rheumatic drug (DMARD) therapies.1,2,3

 

September 18, 2017
More than 80% of patients receiving guselkumab, including patients transitioned from HUMIRA® (adalimumab) to the anti-interleukin (IL)-23 monoclonal antibody, demonstrated PASI 90 and IGA 0/1 scores at week 100

Janssen Research & Development has presented new longer-term data from the open-label extension of the VOYAGE 1 trial demonstrating consistent rates of skin clearance with guselkumab treatment through week 100 among patients with moderate to severe plaque psoriasis receiving the subcutaneously administered anti-interleukin (IL)-23 monoclonal antibody.1

 

July 21, 2017
First investigational targeted biologic in the European Union to receive positive CHMP opinion for atopic dermatitis

Sanofi and Regeneron Pharmaceuticals, Inc have announced that the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorisation of Dupixent® (dupilumab), recommending its approval in Europe for use in adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.

 

July 20, 2017
First and only biologic that selectively targets the IL-17 receptor subunit A

LEO Pharma has announced that the European Commission has granted marketing authorisation for Kyntheum® (brodalumab), a biologic for the treatment of moderate-to-severe plaque psoriasis in adults within the European Union who are candidates for systemic therapy.1

 

Kyntheum® is the first and only biologic that selectively targets the IL-17 receptor subunit A.2,3

 

March 14, 2017
Positive scientific opinion under the Early Access to Medicines Scheme (EAMS) recognises the burden of severe atopic dermatitis and significant unmet patient needs

Sanofi, and its specialty care global business unit, Sanofi Genzyme, announced today that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted dupilumab, an investigational treatment for atopic dermatitis (AD), a positive scientific opinion through the Early Access to Medicines Scheme (EAMS). The decision means that eligible adults with severe AD can access dupilumab before the drug is granted marketing authorisation in the UK. 

 

September 16, 2016
Patients in Scotland now able to access the first fixed-combination cutaneous foam spray for plaque psoriasis

The Scottish Medicines Consortium (SMC) has accepted Enstilar® (calcipotriol/betamethasone dipropionate) for use within NHS Scotland.1

 

This decision confirms that GPs and dermatology clinicians are now authorised to prescribe Enstilar® for the management of all severities of plaque psoriasis in adult patients, aged 18 years or older.2 The SMC’s positive recommendation for Enstilar® follows its UK Marketing Authorisation on 15 April 2016.

July 7, 2016
As a first-of-its kind, the confirmatory clinical safety and efficacy study compares originator etanercept to a biosimilar candidate in psoriasis

Sandoz has announced results from the EGALITY trial in which the primary endpoint of achieving equivalence in Psoriasis Area and Severity Index (PASI) 75 response rates at week 12 was met.

 

The study compared the safety and efficacy of its biosimilar etanercept candidate with the originator product, Enbrel® in patients with moderate-to-severe chronic plaque-type psoriasis and was presented at Psoriasis 2016, the 5th Congress of the Psoriasis International Network (PIN), Paris, France.

 

March 21, 2016
The marketing approval of Enstilar® would make it the first fixed combination topical foam treatment for people living with psoriasis vulgaris in the EU

LEO Pharma announced that it received scientific approval of Enstilar® (calcipotriol/betamethasone dipropionate 50 micrograms/g / 0.5mg/g)  for the treatment of psoriasis vulgaris in patients 18 years of age or older. Enstilar® is an alcohol-free foam formulation for the topical treatment for psoriasis vulgaris.1

 

March 9, 2016
Cosentyx launched as first-line systemic indication for psoriasis in UK in 2015 and recently approved for psoriatic arthritis and ankylosing spondylitis in Europe

Novartis announced new late-breaking data from the head-to-head CLEAR study, demonstrating that Cosentyx (secukinumab) remains superior to Stelara (ustekinumab) in achieving sustained skin clearance (PASI 90 response) at 52 weeks for adults living with moderate-to-severe psoriasis. These findings were presented for the first time at the American Academy of Dermatology (AAD) Annual Meeting in Washington, DC.1

 

March 3, 2016
Study will evaluate efficacy, safety and immunogenicity of adalimumab biosimilar candidate MSB11022 compared with Humira®

Merck, a leading science and technology company, announced the initiation of a global Phase III clinical study of MSB11022, a proposed biosimilar of adalimumab, in chronic plaque psoriasis. This milestone is a strong reflection of Merck’s progress in biosimilars, with the goal of delivering high-quality biologics to patients all over the world.
 

February 29, 2016
Eli Lilly and Company announced that ixekizumab [TALTZ®] has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use

Eli Lilly and Company announced that ixekizumab [TALTZ®] has received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for the treatment of moderate-to-severe plaque psoriasis in adults in the European Union (EU) who are candidates for systemic therapy,1 Ixekizumab is specifically designed to target the cytokine interleukin IL-17A, a protein that plays a key role in driving underlying inflammation in psoriasis.2

 

February 29, 2016
The National Ankylosing Spondylitis Society (NASS) has launched a new campaign aimed at ophthalmologists, dermatologists and gastroenterologists called Back Pain Plus

The National Ankylosing Spondylitis Society (NASS) has launched a new campaign aimed at ophthalmologists, dermatologists and gastroenterologists called Back Pain Plus. The initiative aims to encourage professionals in these fields to think about the link between axial spondyloarthritis including ankylosing spondylitis (AS) and acute anterior uveitis (AAU), psoriasis and inflammatory bowel disease (IBD).
 

As it stands:

October 29, 2015
Global awareness campaign calls for action to effect positive change for the many millions of people who live with psoriasis and psoriatic arthritis worldwide
October 9, 2015
During the 24th Congress of the European Academy of Dermatology and Venereology (EADV), the International Alliance of Dermatology Patient Organizations (IADPO) announced its official launch at the Patient Village of the Congress

During the 24th Congress of the European Academy of Dermatology and Venereology (EADV), the International Alliance of Dermatology Patient Organizations (IADPO) announced its official launch at the Patient Village of the Congress.

 

October 9, 2015
During the 24th Congress of the European Academy of Dermatology and Venereology (EADV), the International Alliance of Dermatology Patient Organizations (IADPO) announced its official launch at the Patient Village of the Congress

During the 24th Congress of the European Academy of Dermatology and Venereology (EADV), the International Alliance of Dermatology Patient Organizations (IADPO) announced its official launch at the Patient Village of the Congress.

 

July 22, 2015
Secukinumab is an innovative new treatment licensed for use in adults with moderate-to-severe plaque psoriasis

The National Institute for Health and Care Excellence (NICE) has issued technology appraisal guidance for Cosentyx™ (secukinumab). Secukinumab is an innovative new treatment licensed for use in adults with moderate-to-severe plaque psoriasis who are candidates for systemic* therapy. (1)

 

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