Pfizer’s anti.corona drug has been approved for home use by the FDA

The FDA, the US Food and Drug Administration, announced today (Wednesday) the approval of the drug of Pfizer Paxlovid for the treatment of coronary heart disease, to prevent the disease from getting worse. The drug is approved for use at home by adults and children at risk (from age 12 and weighing 40 pounds).

An experiment in the drug showed that for verified in the risk group, it reduces the probability of developing a serious illness by 89% -88% compared to placebo (0 deaths in the treatment group compared to 9 in the placebo group), given 3 to 5 days after the onset of symptoms.

Pfizer will start marketing the drug immediately and has already promised the US 10 million doses of the drug between 2021-2022. An agreement has not yet been signed with Israel to purchase the drug, but it was recently hinted in the media that such an agreement is imminent. You can count 120 million doses, instead of 80 as originally planned.The demand for the drug is not as high as for the vaccine, as it is only intended for risk groups and only after it has been verified to Corona, however the demand is expected to be greater than supply at least during 2022.

This approval, like the approval first given to Pfizer’s vaccine against Corona, is a conditional approval to monitor product behavior in the real world. The vaccine has successfully passed the follow-up period and is now approved with full approval as any drug or vaccine. Pfizer believes you can also get the full approval for the drug during 2022.

Pfizer CEO Albert Burla said today that “the approval is another great example of how science will eventually allow us to deal with this epidemic, which even now after two years, continues to disrupt the routine of life and harm the lives of many around the world. This treatment which significantly reduces the number of hospitalizations and deaths, can be given at home and it will change the way we treat Corona, and may allow some of the pressures on our healthcare system and hospitals to be reduced. Pfizer is ready to start marketing in the United States.

Pfizer continues to experiment with the drug to see if even in vertebrates who are not pre-defined as at risk, it can prevent deterioration, which nevertheless occurs in some of these cases. If there is indeed a great benefit to the drug in this group as well, the company may offer it to all Corona nationals in the future.

Compared to the vaccine, Pfizer has established an orderly accessibility program, in which the drug will be offered at a lower price to less affluent countries, and local partners in less-established countries may be allowed to manufacture the drug under license for Pfizer to increase production capacity. These partnerships have allowed the company to raise its forecasts from 80 million units to 120 million to 120 million, the company said in a statement.

Omicron: Good timing for Pfizer

The drug arrives at just the right moment, with the advent of the omicron variant, which infects at non-negligible rates even vaccinated in three doses of the vaccine to Pfizer’s corona. Even before that there was no shortage of Pfizer to whom to sell the drug when the Delta variant raged in the world, but now with Omicron countries are in greater distress and need the drug, as one of the critical tools for managing the management of the disease. If the drug is as effective in the real world as it has been in the experiment, it will be able to change the way it deals with the disease. The drug has so far been found to be indifferent to the variant type, and in laboratory tests significant activity has also been observed against Omicron.

There are several groups of patients who should not take the drug, including those who are allergic to some of its ingredients or those who take several types of drugs, including the drug Alfuzosin to treat prostate tumors, several painkillers, the drug Ranolazine for chest pain in heart patients, several drugs designed to treat arrhythmias. , The drug Colchicine against gout, several antipsychotic drugs, Sildenafil which treats blood pressure health, sedatives and sleep Triazolam and Midazolam, antibiotics called Rifampin, some anticonvulsants, anti-cancer drug – Apalutamide, two drugs from the statin family anti-cholesterol, supplements The mushroom Ergot, and the discourse of Abraham. Johns Wort. Using this impressive drug in conjunction with Pfizer’s drug can result in excessive concentrations of one of the substances in the drug, or impair the efficacy of the drug.

For patients with liver disease, caution is required. There is also a risk of developing resistance to the conventional drug for HIV suppression by taking this drug.

Given that the drug is intended for patients with background diseases and at-risk groups anyway, these provisions leave many potential patients out, so even after approval of this drug, Pfizer “leaves work” for other drugs as well, and in the event of a widespread epidemic, hospitals will not be emptied.

The side effects of the drug that appeared at slightly increased rates compared to the control group were taste distortions, diarrhea, increased blood pressure and muscle aches. The product has not been tested in lactating women and pregnant women yet so currently the drug is not recommended for this group. This is in contrast to the Pfizer vaccine, which has also been tested in pregnant and lactating women and is found to be safe in these groups.

By Editor

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