Erenumab (AIMOVIG™): First Global Approval in US followed by Positive CHMP Opinion – Once-monthly prophylactic approach for adults with Migraine

Erenumab (AIMOVIG™): First Global Approval in US followed by Positive CHMP Opinion – Once-monthly prophylactic approach for adults with Migraine

Erenumab (AIMOVIG™, erenumab-aooe) was launched in the US in July 2018, following its first global approval in the region in May, which was reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2]. Also in May 2018, the agent received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). Continue reading “Erenumab (AIMOVIG™): First Global Approval in US followed by Positive CHMP Opinion – Once-monthly prophylactic approach for adults with Migraine”

Burosumab (Crysvita®): First Global Approval – Infrastructure repair for patients with X-linked hypophosphataemia

Burosumab (Crysvita®): First Global Approval – Infrastructure repair for patients with X-linked hypophosphataemia

The recent first global approval of burosumab has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2]. Continue reading “Burosumab (Crysvita®): First Global Approval – Infrastructure repair for patients with X-linked hypophosphataemia”

Benralizumab (Fasenra™): First Global Approval – eosinophil depletion and a convenient maintenance regimen for patients with severe asthma.

Benralizumab (Fasenra™): First Global Approval – eosinophil depletion and a convenient maintenance regimen for patients with severe asthma.

In November 2017, benralizumab (Fasenra™), developed by Kyowa Hakka Kirin & AstraZeneca, received its first global approval in the USA as add-on maintenance therapy for patients with severe eosinophilic asthma who are at least 12 years old. [1][2] Continue reading “Benralizumab (Fasenra™): First Global Approval – eosinophil depletion and a convenient maintenance regimen for patients with severe asthma.”

Semaglutide (Ozempic®): First Global Approval – Plus rapid follow-ups in major markets – will this once-weekly prefilled pen write the future for convenience in patients with type 2 Diabetes Mellitus?

Semaglutide (Ozempic®): First Global Approval – Plus rapid follow-ups in major markets – will this once-weekly prefilled pen write the future for convenience in patients with type 2 Diabetes Mellitus?

On December 5th 2017, semaglutide (Ozempic®), developed by Novo Nordisk, received its first global approval in the US.[1] Nine days later the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion in the EU.[2] This was followed swiftly by Health Canada’s approval in January 2018.[3] [4] In all cases, semaglutide was approved for use in adults with type 2 diabetes mellitus, as an adjunct to diet and exercise to improve glycaemic control. The drug is dispensed as prefilled pens for subcutaneous injection once weekly. Semaglutide is a glucagon-like peptide (GLP-1) receptor agonist that stimulates insulin and suppresses glucagon secretion in a glucose-dependent manner.[3] It is administered on the same day each week, at any time and without regard for food intake.[1] Continue reading “Semaglutide (Ozempic®): First Global Approval – Plus rapid follow-ups in major markets – will this once-weekly prefilled pen write the future for convenience in patients with type 2 Diabetes Mellitus?”

Emicizumab-kxwh (Hemlibra®): First Global Approval – novel mechanism and once-weekly regimen hoped to revolutionise routine prophylaxis in patients with haemophilia A

Emicizumab-kxwh (Hemlibra®): First Global Approval – novel mechanism and once-weekly regimen hoped to revolutionise routine prophylaxis in patients with haemophilia A

The recent first global approval of emicizumab-kxwh has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2]. Continue reading “Emicizumab-kxwh (Hemlibra®): First Global Approval – novel mechanism and once-weekly regimen hoped to revolutionise routine prophylaxis in patients with haemophilia A”

Abaloparatide (Tymlos™): First Global Approval – bone formation fends off fragility fractures in postmenopausal women with high-risk osteoporosis

Abaloparatide (Tymlos™): First Global Approval – bone formation fends off fragility fractures in postmenopausal women with high-risk osteoporosis

The recent first global approval of abaloparatide has been reviewed in detail in the First Global Approval report in Adis journal Drugs, based on the development milestones tracked in AdisInsight. Continue reading “Abaloparatide (Tymlos™): First Global Approval – bone formation fends off fragility fractures in postmenopausal women with high-risk osteoporosis”

Dupilumab (Dupixent®): First Global Approval – don’t just scratch the surface – go skin deep and relieve the symptoms of uncontrolled eczema

Dupilumab (Dupixent®): First Global Approval – don’t just scratch the surface – go skin deep and relieve the symptoms of uncontrolled eczema

The recent first global approval of dupilumab has been reviewed in detail in the First Global Approval report in Adis journal Drugs, based on the development milestones tracked in AdisInsight. Continue reading “Dupilumab (Dupixent®): First Global Approval – don’t just scratch the surface – go skin deep and relieve the symptoms of uncontrolled eczema”

Sarilumab (Kevzara™): First Global Approval – an alternative MOA to TNF agents for rheumatoid arthritis

Sarilumab (Kevzara™): First Global Approval – an alternative MOA to TNF agents for rheumatoid arthritis

AdisInsightThe recent first global approval of sarilumab has been reviewed in detail in the First Global Approval report in Adis journal Drugs, based on the development milestones tracked in AdisInsight.

In February 2017, sarilumab (Kevzara™), developed by Sanofi and Regeneron Pharmaceuticals, received its first global approval in Canada for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more biologic or non-biologic disease-modifying anti-rheumatic drugs (DMARDs). Continue reading “Sarilumab (Kevzara™): First Global Approval – an alternative MOA to TNF agents for rheumatoid arthritis”