These Drugs Find Their Way to European Union
After the approval of Bristol-Myers Squibb (BMS) and Abbvie’s Empliciti™ (elotuzumab) by European Commission (EC) as the first and the only immunostimulatory antibody to be approved in European Union for adult multiple myeloma treatment. These are other FDA approved drugs which received a positive opinion from CHMP last week.
It will be further reviewed by EC to gain entry to EU as well as European Economic Area members, Iceland, Liechtenstein and Norway.
Note: To market any drug in the EU, the company need to impress the Committee for Medicinal Products for Human Use (CHMP) of European Medicines Agency (EMA). Based on their opinion the drug is reviewed by the EC for its approval in EU.
#1. Zepatier- Hepatitis C
|Company Name:||Merck & Co (New Jersey, United States)|
|Drug Name:||Zepatier™ (elbasvir and grazoprevir)|
|Disease:||Hepatitis C Virus (HCV) Infection in adult patients|
|FDA Approval:||January 2016|
Zepatier is a once daily, single tablet, fixed dose combination therapy (50mg/100mg) for treatment of chronic HCV genotype 1 or 4 infection in adults. Elbasvir is a HCV NS5A inhibitor and grazoprevir is a HCV NS3/4A protease inhibitor, they are direct-acting antiviral agent against HCV. EC decision can be anticipated in mid-2016.
#2. Adcetris- Hodgkin Lymphoma
|Company Name:||Takeda (Osaka, Japan)|
|Drug Name:||Adcetris® (brentuximab vedotin)|
|Disease:||Hodgkin Lymphoma (HL) CD30 in adult patients|
|FDA Approval:||August 2011 for treatment of Hodgkin Lymphoma (HL) and a rare lymphoma called systemic anaplastic large cell lymphoma (ALCL)|
Adcetris® is an antibody-drug conjugate (ADC) in which the antibody direct the drug to target on lymphoma cells called CD30. Adcetris® also treats the increased risk of relapse or progression following an autologous stem cell transplant (ACS). Phase III trial, Aethera explored a consolidation therapy for HL patients following ACS. In this context Adcetris® can serve as an interesting treatment option. Positive opinion of CHMP is for the extension of the current conditional approval ADCETRIS® (brentuximab vedotin) and recommended its approval for the treatment of adult patients with Hodgkin lymphoma CD30 + increased risk of relapse or progression following an ACS.
#3. Kyprolis- Multiple Myeloma
|Company Name:||Amgen (California, United States)|
|Drug Name:||Kyprolis® (carfilzomib)|
|Disease:||Relapsed multiple Myeloma|
July 2012 for the treatment of multiple myeloma in patients who prior received at least two therapies including treatment with bortezomib and an immunomodulatory therapy. January 2016 as combination therapy with dexamethasone or with lenalidomide plus dexamethasone for the treatment of relapsed or refractory multiple myeloma.
Kyprolis is a selective proteasome inhibitor which received positive opinion of CHMP to extend current indication for Kyprolis® (carfilzomib) to include treatment in combination with dexamethasone alone for adult patients with multiple myeloma who have earlier received one therapy. The positive opinion is based on Phase III head-to-head ENDEAVOR study in which Kyprolis® plus dexamethasone showed doubled progression free survival versus Velcade® plus dexamethasone.
#4. Humira- Non-infectious Uveitis
|Company Name:||AbbVie (Illinois, United States)|
|Drug Name:||Humira® (adalimumab)|
|Disease:||Certain form of non-infectious uveitis (can damage vision)|
Humira® has been approved by FDA for treatment of diverse symptoms, rheumatoid arthritis, psoriatic arthritis, ankylosing spondilitis, Crohn’s disease, moderate to severe chronic psoriasis and juvenile idiopathic arthritis, ulcerative colitis.
Non-infectious uveitis is characterized by the inflammation of the uvea which is the middle layer of the eye.It can be caused by an eye injury or due to any disease anywhere else in the body. TNF-α bind to TNF-α receptors to initiate inflammatory responses in autoimmune diseases. Humira® binds to the tumor necrosis factor-alpha (TNF-α) to reduce the inflammatory response.
The positive recommendation of CHMP was based on two pivotal Phase III studies (VISUAL-I and VISUAL-II) which showed significantly lower risk for uveitic flare or decrease in visual acuity compared to placebo.
#5. Revestive- Short Bowel Syndrome
|Company Name:||Shire (Dublin, Republic of Ireland)|
|Drug Name:||Revestive® (Teduglutide)|
|Disease:||Short Bowel Syndrome (SBS) in paediatric patients|
|FDA Approval:||December 2012, under the brand name Gattex for treatment of SBS in adults|
SBS is a rare malabsorption disorder. It typically arises due to extensive resection of bowel due to conditions like Crohn’s disease, ischemia etc. Teduglutide is available in Europe for the treatment of adult patients with SBS under brand name Gattex.
Revestive is a recombinant analogue of human glucagon-like peptide 2 (GLP-2) . It helps in improving the intestinal mucosa, intestinal blood flow,reduces gastrointestinal motility and secretion of gastric acid. The positive opinion of CHMP is for the extension of approval of Revestive, 5mg powder and solvent for solution for injection for children of 1 year to 17 years. EC’s final decision is anticipated in August 2016.
Featured image credit: STRASBOURG FRANCE – JANUARY 28 2014 © hadrian (Stock Photo ID: 81523928)