Roche Leads New Drug Approvals

A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Roche. 

Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday October 12, 2016 to Tuesday October 18, 2016.

Allergan Gets Marketing Authorization in Sweden for Obesity Drug
Allergan has received marketing authorization in Sweden for Belkyra (deoxycholic acid), its obesity treatment, after being granted approval by the Swedish Medical Products Agency (MPA). Belkyra is a prescription medicine for moderate-to-severe convexity or fullness associated with submental fat (often called double chin) in adults when the presence of submental fat has a psychological impact for the patient.

Belkyra contains a synthetic version of deoxycholic acid which imitates naturally-occurring deoxycholic acid. It is designed to cause the destruction of fat cells when injected into subcutaneous fat, according to the company. Belkyra was evaluated through a decentralized procedure, with the Swedish MPA acting as the reference member state and included 20 other countries in the European Union as well as Iceland and Norway. Belkyra is already licensed in Canada, Australia, Iceland, Hungary, Austria, Lithuania, Estonia, Latvia, Romania, Bulgaria, and Norway as well as in the US as Kybella.

Source: Allergan

FDA OKs Roche’s Lucentis Prefilled Syringe
Genentech, a member of the Roche Group, has received approval from the US Food and Drug Administration (FDA) for Lucentis (ranibizumab injection) 0.5 mg prefilled syringe (PFS) as a new method of administering the medicine, which is approved for wet age-related macular degeneration (AMD) and macular edema after retinal vein occlusion (RVO). Lucentis is a vascular endothelial growth factor inhibitor designed to bind to and inhibit VEGF-A, a protein that is believed to play a role in the formation of new blood vessels and the hyperpermeability of the vessels, according to information from the company.

The Lucentis PFS allows physicians to eliminate several steps in the preparation and administration process, including disinfecting the vial, attaching a filter needle, drawing the medicine from the vial using the needle, removing the filter needle from the syringe and replacing with an injection needle. With the Lucentis PFS, physicians attach the injection needle to the syringe and adjust the dose prior to administration, according to Genentech.

The Lucentis 0.5 mg PFS is expected to be available in early 2017. Lucentis was approved by the FDA to treat wet AMD in 2006 and to treat macular edema after RVO in 2010. In the US, Lucentis is also indicated for diabetic macular edema (DME) and diabetic retinopathy in people with DME. Lucentis was developed by Genentech. The company retains commercial rights in the US and Novartis has exclusive commercial rights for the rest of the world.

Outside the US, Lucentis is approved in more than 100 countries to treat patients with wet AMD, for the treatment of DME, and due to macular edema secondary to both branch retinal vein occlusion and central retinal vein occlusion.

Lucentis was also granted priority review by the FDA for treating myopic choroidal neovascularization, a complication of severe near-sightedness that can lead to blindness.

Source: Genentech

EC Grants Shire Marketing Authorization for Cancer Drug
The European Commission (EC) has granted marketing authorization to Shire for Onivyde (pegylated liposomal irinotecan hydrochloride trihydrate) for metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil and leucovorin, in adult patients who have progressed following gemcitabine-based therapy.

With this approval, Shire is authorized to market Onivyde in the 28 Member States of the European Union, as well as in Iceland, Liechtenstein and Norway. The drug was previously approved in the US by the US Food and Drug Administration in October 2015 for patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.

Source: Shire

FDA Approves Protein Sciences’ Quadrivalent Flu Vaccine
Protein Sciences Corporation has received approval from the US Food and Drug Administration for its quadrivalent formulation of Flublok influenza vaccine, which is designed to protect against four strains of influenza, three of the same strains found in trivalent Flublok plus an additional B strain. Flublok Quadrivalent is approved for adults 18 and older and will be available in pre-filled syringes beginning in 2017.

Source: Protein Sciences Corporation

Teva Launches Generic Oral Contraceptive
Teva Pharmaceutical Industries has launched Rajanitm (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.02 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg), the generic equivalent of Bayer’s Beyaz (drospirenone, ethinyl estradiol, levomefolate calcium), an oral contraceptive, in the US.

Rajanitm is available in a 28-day blister pack dispenser, for use by women to: prevent pregnancy;
treat symptoms of premenstrual dysphoric disorder in women choosing to use an oral contraceptive for contraception; treat moderate acne for women at least 14 years old if the patient desires an oral contraceptive for birth control; and raise folate levels in women who choose to use an oral contraceptive for contraception.

Beyaz had annual sales of approximately $133 million in the US, according to IMS data as of July 2016 and as cited by Teva.

Source: Teva Pharmaceutical Industries

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