Bictegravir (Biktarvy®): Positive CHMP Opinion in the EU

Bictegravir (Biktarvy®): Positive CHMP Opinion in the EU

Bictegravir, in combination with emtricitabine and alafenamide (Biktarvy ®) received its first global approval in the US in February 2018.[1] Subsequently, in April, this fixed-dose triple combination has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA).[2] Continue reading “Bictegravir (Biktarvy®): Positive CHMP Opinion in the EU”

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.”

Ocrelizumab (Ocrevus®): Now also approved in the EU

Ocrelizumab (Ocrevus®): Now also approved in the EU

Ocrelizumab has now also been approved in the EU for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical and imaging features.[1] This European approval in January 2018, followed two previous approvals in 2017, granted to Genentech, the developers,  initially in the US (March) [2] and later in Canada (August)[3] for the same indication. Continue reading “Ocrelizumab (Ocrevus®): Now also approved in the EU”

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?”

Letermovir (Prevymis™): First Global Approval – Distinct mechanism of action provides protection against CMV in recipients of HSCT

Letermovir (Prevymis™): First Global Approval – Distinct mechanism of action provides protection against CMV in recipients of HSCT

The recent first global approval of letermovir 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 “Letermovir (Prevymis™): First Global Approval – Distinct mechanism of action provides protection against CMV in recipients of HSCT”

AdisInsight is PRIMEd

AdisInsight is PRIMEd

Adis adds PRIME status to AdisInsight drug profiles.

In 2016, the European Medicines Agency launched PRIME – a program to enhance support for the development of medicines that target an unmet medical need. This voluntary program is based on enhanced interaction and early dialogue with developers of promising medicine, to optimise development plans and speed up evaluation so that these medicines can reach patients earlier.

Continue reading “AdisInsight is PRIMEd”