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FDA Blocks Monthly HIV Drug Combo

T-cell infected by HIV

T-cell infected by HIV (NIAID, Flickr)

23 Dec. 2019. The U.S. Food and Drug Administration rejected a combination of experimental and existing drugs given once a month to treat HIV. The application to FDA was made to approve a single monthly injection of the experimental drug cabotegravir by ViiV Healthcare in London, and the current HIV drug rilpivirine, marketed as Edurant by Janssen Pharmaceuticals, a division of Johnson & Johnson, in Titusville, New Jersey.

ViiV Healthcare and Janssen say FDA expressed its concerns in a complete response letter, correspondence for rejecting a new drug application to the agency. ViiV — a joint venture of drug makers GlaxoSmithKline, Pfizer, and Shionogi to develop HIV drugs — and Janssen say FDA raised objections to proposed chemistry, manufacturing, and controls processes for the combination drug. These processes often involve a product’s identity, strength or potency, quality, and purity. The companies point out that FDA did not raise any safety issues with the proposed drug combination.

Cabotegravir is under development by ViiV as both an oral drug and long-acting injectable treatment for HIV. The drug blocks an enzyme called integrase that inserts DNA from HIV viruses into white blood cells in the immune system. By blocking this integration of viral DNA into immune system cells, HIV cells cannot multiply and the amount of HIV is reduced in the body.

Rilpivirine, or Edurant, is already approved by FDA as a daily therapy for HIV, but is prescribed for certain teens and adults with HIV only when taken with other drugs. Rilpivirine blocks an enzyme called reverse transcriptase that prevents HIV from multiplying, and thus reduces the amount of HIV in the body.

ViiV and Janssen tested the two drugs, formulated into an injectable treatment given once a month, in a series of clinical trials. In a late-stage trial reported in October 2018, the injected cabotegravir and rilpivirine combination given once a month shows the same efficacy as a daily three-drug combination among adults who already succeeded in reducing their HIV levels. Results from another late-stage trial reported in August of this year shows the cabotegravir-rilpivirine combination injected every eight weeks works as well as the drugs given every four weeks.

ViiV Healthcare and Janssen say they will work with FDA to determine the appropriate next steps for advancing this HIV treatment. As reported by Science & Enterprise in April 2019, FDA approved a two-drug combination brand-named Dovato by ViiV Healthcare, as a daily oral drug to lower HIV viral loads.

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Disclosure: The author owns shares in Johnson & Johnson and Pfizer.

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