Baloxavir Marboxil (XOFLUZA™): First Global Approval – a One-Pill Wonder for Patients with Influenza

Baloxavir Marboxil (XOFLUZA™): First Global Approval – a One-Pill Wonder for Patients with Influenza

The recent first global approval of baloxavir marboxil 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].

Japan was first country to approve baloxavir marboxil (XOFLUZA™) in February 2018, under Sakigake fast track review. The agent is being jointly developed by Shionogi and Roche and was approved for the treatment of influenza types A and B in paediatric and adult patients. Continue reading “Baloxavir Marboxil (XOFLUZA™): First Global Approval – a One-Pill Wonder for Patients with Influenza”

Apalutamide (Erleada™): First Global Approval – Reduces risk of metastasis in patients with non-metastatic, castration-resistant prostate cancer

Apalutamide (Erleada™): First Global Approval – Reduces risk of metastasis in patients with non-metastatic, castration-resistant prostate cancer

The recent first global approval of Apalutamide 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]

In mid-February 2018, apalutamide (Erleada™), developed by Janssen, received its first global approval in the US for the treatment of non-metastatic, castration-resistant prostate cancer (NM-CRPC). Continue reading “Apalutamide (Erleada™): First Global Approval – Reduces risk of metastasis in patients with non-metastatic, castration-resistant prostate cancer”

Bictegravir (Biktarvy®): First Global Approval – an all-in-one package: A single-tablet HIV-1 treatment regimen

Bictegravir (Biktarvy®): First Global Approval – an all-in-one package: A single-tablet HIV-1 treatment regimen

The recent first global approval of bictegravir 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].

Bictegravir (Biktarvy®), developed by Gilead Sciences, received its first global approval in February 2018 in the USA as a fixed-dose combination, with emtricitabine and tenofovir alafenamide. Continue reading “Bictegravir (Biktarvy®): First Global Approval – an all-in-one package: A single-tablet HIV-1 treatment regimen”

Ertugliflozin (Steglatro™): First Global Approval – followed swiftly by FDCs in US and EU… good news for patients with type-two diabetes mellitus

Ertugliflozin (Steglatro™): First Global Approval – followed swiftly by FDCs in US and EU… good news for patients with type-two diabetes mellitus

In December 2017, ertugliflozin (Steglatro™), developed by Merck and Pfizer, received its first global approval in the US for use in conjunction with exercise and diet to improve glycaemic control in adults with type-2 diabetes mellitus (T2DM). [1 Continue reading “Ertugliflozin (Steglatro™): First Global Approval – followed swiftly by FDCs in US and EU… good news for patients with type-two diabetes mellitus”

Durvalumab (IMFENZI®): Follow up Approval for NSCLC, a second indication, in USA

Durvalumab (IMFENZI®): Follow up Approval for NSCLC, a second indication, in USA

In February 2018, durvalumab (IMFENZI®) was approved in the US for the treatment of patients with unresectable, stage III non-small cell lung cancer (NSCLC), whose cancer has not progressed after chemoradiation therapy.[1] Continue reading “Durvalumab (IMFENZI®): Follow up Approval for NSCLC, a second indication, in USA”

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.”

Netarsudil (Rhopressa®): First Global Approval – New MOA ready to ROCK the world of patients with Glaucoma

Netarsudil (Rhopressa®): First Global Approval – New MOA ready to ROCK the world of patients with Glaucoma

The recent first global approval of netarsudil ophthalmic solution 0.02% 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].

In December 2017 netarsudil (Rhopressa®), developed by Aerie Pharmaceuticals, received its first global approval in the US for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.[3] Interestingly, this approval was made two months in advance of the official scheduled Prescription Drug User Fee Act (PDUFA) goal date of 28th February 2018.[4] Continue reading “Netarsudil (Rhopressa®): First Global Approval – New MOA ready to ROCK the world of patients with Glaucoma”

Tropical virus Chikungunya in the eye of a storm

Tropical virus Chikungunya in the eye of a storm

Chikungunya virus is a mosquito-borne viral infection that presents with headache, rash, muscle pain, and joint swelling; the latter two symptoms can persist and be debilitating for up to 6 months after initial infection.[1]

Known outbreaks have occurred in several countries located in Europe, Africa, Asia, the Pacific and Indian Oceans and also the Americas. As well as local transmission via mosquitoes, more wide-spread transmission by infected travellers is feared.

Currently, according to the Centers for Disease Control and Prevention (CDC), the only effective prophylaxis available for this viral infection is to not get bitten by mosquitoes! Continue reading “Tropical virus Chikungunya in the eye of a storm”

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”