AbbVie drops Kaletra rights for broader COVID-19 treatment; Gilead halts access to experimental drug

With the new coronavirus hitting the globe more extensively, a manufacturer of COVID-19 alternative treatment and an experimental drug maker took contrasting moves recently.

AbbVie, the developer of anti-HIV drug Kaletra (ingredient: lopinavir/ritonavir), said it would give up the global patent of the drug to widen access to the drug amid the COVID-19 pandemic.

As the global demands for Kaletra surged with the intensifying pandemic, the drugmaker’s decision aims to allow the use of generic copies produced in India or Southeast Asia.

Some industry watchers said it would not have been too difficult for AbbVie to give up the Kaletra rights.

AbbVie launched Kaletra more than 20 years ago, and the patent is to expire soon. Except for some developing countries, Kaletra is not actively used in HIV treatment.

Physicians have recently shifted the HIV treatment toward integrase strand transfer inhibitors (INSTIs), which are more effective and safer than conventional drugs. InSTI-based drugs by Gilead and GSK have taken almost all of the HIV treatment market.

According to AbbVie’s 2019 sales report, Kaletra’s annual revenue recorded $238 million, less than 1 percent of the company’s total annual sales of $33.26 billion.

However, other observers said the company’s drop of Kaletra patent was a bold decision, compared to that of Gilead.

Gilead recently announced that it would temporarily stop granting patients’ access to remdesivir, an investigational drug against COVID-19, due to spiking demand for the drug in the U.S. and Europe.

However, severe COVID-19 patients, children under 18 and pregnant women could still get remdesivir for compassionate use, the company noted.

Gilead initially developed the agent as the treatment of the Ebola virus but failed to prove its effect inside the body.

In January, U.S. health officials used it to treat the first U.S. case of the COVID-19 for compassionate use, and the patient showed clinical improvement in just one day, which drew the world’s attention. Since then, Gilead has been conducting phase-3 studies in the U.S., China, Korea, and several other countries to win the indication for COVID-19.

Earlier, the company had said it would support the compassionate use of remdesivir as much as possible amid the growing attention on its potential for the treatment of COVID-19.

The U.S. Food and Drug Administration recently granted orphan drug status to remdesivir for treating the virus.

The status gives Gilead various benefits, including the FDA’s fast-track drug review.

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