PHARMACY

FDA gives green light to 60 Degrees Pharmaceutical’s Arakoda for malaria prevention

BY Sandra Levy

The Food and Drug Administration has given the nod to 60 Degrees Pharmaceuticals’ Arakoda (tafenoquine) tablets for the prevention of malaria in patients aged 18 years and older.

Malaria is a life-threatening disease transmitted through the bite of an infected mosquito.

This is the first FDA approval of a new drug for the prevention of malaria in 18 years.

Arakoda is supplied in 100 mg tablets for oral use only. After an initial loading dose prior to traveling, it is intended to be taken once a week.

Tafenoquine is an 8-aminoquinoline chemically derived from primaquine, with activity against all types of malaria Tafenoquine was originally discovered by scientists at the Walter Reed Army Institute of Research (WRAIR).

The approval was based on a collaborative effort by the United States Army and 60P, involving over 21 clinical trials and over 3,100 trial subjects, to develop tafenoquine as a weekly prophylactic drug for the prevention of malaria.

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PHARMACY

Regeneron and Sanofi launch Kevzara Pen for RA patients

BY Sandra Levy

Regeneron and Sanofi have announced the availability of Kevzara (sarilumab) pre-filled pen for the treatment of adults with moderately to severely active rheumatoid arthritis. Kevzara was approved by the Food and Drug Administration in May 2017.

The Kevzara pre-filled pen is the only biologic RA therapy that is currently available in the United States as a button-free pen, according to the two companies. The pre-filled pen was designed to help patients who have grip and dexterity limitations.

Kevzara is indicated for the treatment of adult patients with moderately to severely active RA who have had an inadequate response or intolerance to one or more disease modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX).

Sanofi and Regeneron said Kevzara is a human monoclonal antibody that binds to the interleukin-6 receptor (IL-6R) and has been shown to inhibit IL-6R mediated signaling. IL-6 is a cytokine in the body that, in excess and over time, can contribute to the inflammation associated with RA.

 

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FDA commissioner Gottlieb touts record number of generic drug approvals in July

BY Sandra Levy

The Food and Drug administration beat its record for drug approvals in July, FDA commissioner Scott Gottlieb tweeted yesterday. “July saw the highest number of approval actions in the history of the generic drug program in a single month with 126 total approvals (96 full) approvals plus 30 tentative approvals,” Gottlieb said.

The Activities Report of the Generics Drug Program shows that June 2018 was also a month in which generic drug approvals soared, with 74 approvals, and 18 tentative approvals. In October 2017, the FDA approved 87 generic drugs. In November 2017 the FDA gave the nod to 87 generic drugs.

In December 2017 there were 78 generic drug approvals. January 2018 saw only 25 generic approvals. February 2018 had the FDA giving the nod to 32 generics and in March, generic drug approvals tallied 57.

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