A panel of U.S. health advisers on Tuesday narrowly backed a closely watched COVID-19 pill from Merck, setting the stage for a likely authorization of the first drug that Americans could take at home to treat the coronavirus. The Food and Drug Administration panel voted 13-10 that the antiviral drug’s benefits outweigh its risks, including potential birth defects if used during pregnancy. “I see this as an incredibly difficult decision with many more questions than answers,” said panel chair Dr. Lindsey Baden of Harvard Medical School, who voted in favor of the drug. He said FDA would have to carefully tailor the drug’s use for patients who stand to benefit most. The recommendation came after hours of debate about the drug’s modest benefits and potential safety issues. Most experts backing the treatment stressed that it should not be used by anyone who is pregnant and called on FDA to recommend extra precautions before the drug is prescribed, such as pregnancy tests for women of child-bearing age. The vote specifically backed the drug for adults with mild-to-moderate COVID-19 who face the greatest risks, including older people and those with conditions like obesity and asthma. Most experts also said the drug shouldn’t be used in vaccinated people, who weren’t part of Merck’s research and haven’t been shown to benefit. Read: US expected to toughen testing requirement for travelers The FDA isn’t bound by the panel’s recommendation and is expected to make its own decision before year’s end. The antiviral is already authorized in the U.K. The drug, molnupiravir, could provide a much-needed weapon against the virus as colder weather pushes case counts higher and U.S. officials brace for the arrival of the new omicron variant. Merck hasn’t specifically tested its drug against the new variant but said it should have some potency based on its effectiveness against other strains of coronavirus. That uncertainty frustrated many panelists as they grappled with whether to back the treatment for millions of Americans. “With no data saying it works with new variants, I really think we need to be careful about saying that this is the way to go,” said Dr. David Hardy of Charles Drew University School of Medicine and Science, who ultimately voted to back the drug. On Friday, Merck released updated data that paint a less compelling picture of the drug’s effectiveness than just a few weeks earlier. Merck said final study results showed molnupiravir reduced hospitalization and death by 30% among adults infected with the coronavirus, when compared with adults taking a placebo. That effect was significantly less than the 50% reduction it first announced based on incomplete results. For many panelists, the modest effect wasn’t enough to outweigh the drug’s potential toxicity to human fetuses. “Given the large potential population affected, the risk of widespread effects on potential birth defects has not been adequately studied,” said Dr. Sankar Swaminathan of the University of Utah School of Medicine, who voted against the drug. Read: Authorities: Student kills 3, wounds 8 at Michigan school FDA scientists told the panelists earlier Tuesday that company studies in rats showed the drug caused birth defects when given at very high doses. FDA staffers concluded the data “suggest that molnupiravir may cause fetal harm when administered to pregnant individuals.” The agency is weighing a blanket restriction against any use in pregnant women or allowing doctors to use the drug in rare cases. Some panelists said that option should be left open for pregnant mothers who have high-risk COVID-19 and may have few other treatment options. Dr. Janet Cragan, who backed the drug, said that even with tight restrictions some pregnant women would inevitably take the antiviral. “I don’t think you can ethically tell a woman with COVID-19 that she can’t have the drug if she’s decided that’s what she needs,” said Cragan, a panel member and staffer with the Centers for Disease Control and Prevention. “I think the final decision has to come down to the individual woman and her provider.” Merck’s drug uses a novel approach to fight COVID-19: It inserts tiny errors into the coronavirus’ genetic code to stop it from reproducing. That genetic effect has raised concerns that the drug could spur more virulent strains of the virus. FDA regulators said Tuesday that risk is theoretical but many panelists said it should be carefully tracked in follow-up studies. Antiviral pills have long been seen as a key advance beyond currently used antibody drugs, which must be injected or infused by health professionals. But given the shortcomings of Merck’s data, several experts said they would prioritize patients to receive the older drugs. While Merck and its partner Ridgeback Biotherapeutics were the first to submit their COVID-19 pill to the FDA, rival drugmaker Pfizer is close behind with its own pill under review. Pfizer’s drug is part of a decades-old family of antiviral pills known as protease inhibitors, a standard treatment for HIV and hepatitis C. They work differently than Merck’s pill and haven’t been linked to the kind of mutation concerns raised with Merck’s drug. Pfizer said this week that its drug shouldn’t be affected by the omicron variant’s mutations. Both drugs require patients to take multiple pills, twice a day for five days. The U.S. government has agreed to purchase 10 million treatment courses of Pfizer’s drug, if it’s authorized. That’s more than three times the government’s purchase agreement with Merck for 3.1 million courses of molnupiravir.
Pfizer asked U.S. regulators Tuesday to authorize its experimental pill for COVID-19, setting the stage for a likely launch this winter of a promising treatment that can be taken at home. The company’s filing comes as new infections are rising once again in the United States, driven mainly by hot spots in states where colder weather is driving more Americans indoors. Pfizer’s pill has been shown to significantly cut the rate of hospitalizations and deaths among people with coronavirus infections. The Food and Drug Administration is already reviewing a competing pill from Merck and several smaller drugmakers are also expected to seek authorization for their own antiviral pills in the coming months. Read: Pfizer agrees to let other companies make its COVID-19 pill “We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients, and we look forward to working with the U.S. FDA on its review of our application,” said Pfizer CEO Albert Bourla, in a statement. Specifically, Pfizer wants the drug available for adults who have mild-to-moderate COVID-19 infections and are at risk of becoming seriously ill. That’s similar to how other drugs are currently used to treat the disease. But all FDA-authorized COVID-19 treatments require an IV or injection given by a health professional at a hospital or clinic. The FDA is holding a public meeting on the Merck pill later this month to get the opinion of outside experts before making its decision. The agency isn’t required to convene such meetings and it’s not yet known whether Pfizer’s drug will undergo a similar public review. Some experts predict COVID-19 treatments eventually will be combined to better protect against the worst effects of the virus. Pfizer reported earlier this month that its pill cut hospitalizations and deaths by 89% among high-risk adults who had early symptoms of COVID-19. The company studied its pill in people who were unvaccinated and faced the worst risks from the virus due to age or health problems, such as obesity. If authorized, the FDA will have to weigh making the pill available for vaccinated people dealing with breakthrough infections, since they weren’t part of the initial tests. Read: US announces another 14mn Pfizer jabs for Bangladesh For best results, patients need to start taking the pills within three days of symptoms, underscoring the need for speedy testing and diagnosis. That could be a challenge if another COVID-19 surge leads to testing delays and shortages seen last winter. Pfizer’s drug is part of a decades-old family of antiviral drugs known as protease inhibitors, which revolutionized the treatment of HIV and hepatitis C. The drugs block a key enzyme which viruses need to multiply in the human body. That’s different than the Merck pill, which causes tiny mutations in the coronavirus until the point that it can’t reproduce itself. On Tuesday, Pfizer signed a deal a with U.N.-backed group to allow generic drugmakers to produce low-cost versions of the pill for certain countries. Merck has a similar deal for its pill, which was authorized in Britain earlier this month. Read: Pfizer asks FDA to OK COVID-19 booster shots for all adults The U.S. has approved one other antiviral drug for COVID-19, remdesivir, and authorized three antibody therapies that help the immune system fight the virus. But they usually have to be given via time-consuming infusions by health professionals, and limited supplies were strained by the last surge of the delta variant. The U.S. government has already committed to purchasing Merck’s pill. Federal authorities were in negotiations with Pfizer to buy millions of doses of its pill, according to an official familiar with the matter.
Drugmaker Pfizer Inc. has signed a deal with a U.N.-backed group to allow other manufacturers to make its experimental COVID-19 pill, a move that could make the treatment available to more than half of the world’s population. In a statement issued Tuesday, Pfizer said it would grant a license for the antiviral pill to the Geneva-based Medicines Patent Pool, which would let generic drug companies produce the pill for use in 95 countries, making up about 53% of the world’s population. The deal excludes some large countries that have suffered devastating coronavirus outbreaks. For example, while a Brazilian drug company could get a license to make the pill for export to other countries, the medicine could not be made generically for use in Brazil. Still, health officials said the fact that the deal was struck even before Pfizer’s pill has been authorized anywhere, could help to end the pandemic quicker. “It’s quite significant that we will be able to provide access to a drug that appears to be effective and has just been developed, to more than 4 billion people,” Esteban Burrone, head of policy at the Medicines Patent Pool, said. Also Read: Pfizer says COVID-19 pill cut hospital, death risk by 90% He estimated that other drugmakers would be able to start producing the pill within months, but acknowledged the agreement wouldn’t please everyone. “We try to strike a very delicate balance between the interests of the (company), the sustainability required by generic producers and most importantly, the public health needs in lower and middle-income countries,” Burrone said. Under the terms of the agreement, Pfizer will not receive royalties on sales in low-income countries and will waive royalties on sales in all countries covered by the agreement while COVID-19 remains a public health emergency. Earlier this month, Pfizer said its pill cut the risk of hospitalization and death by nearly 90% in people with mild to moderate coronavirus infections. Independent experts recommended halting the company’s study based on its promising results. Also Read: FDA paves way for Pfizer COVID-19 vaccinations in young kids Pfizer said it would ask the U.S. Food and Drug Administration and other regulators to authorize the pill as soon as possible, Since the pandemic erupted last year, researchers worldwide have raced to develop a pill to treat COVID-19 that can be taken at home easily to ease symptoms, speed recovery and keep people out of the hospital. At the moment, most COVID-19 treatments must be delivered intravenously or by injection. Britain authorized the Merck’s COVID-19 pill earlier this month, and it is pending approval elsewhere. In a similar deal with the Medicines Patent Pool announced in October, Merck agreed to let other drugmakers make its COVID-19 pill, molnupiravir, available in 105 poorer countries. Doctors Without Borders said it was “disheartened” that the Pfizer deal does not make the drug available to the entire world, noting that the agreement announced Tuesday also excludes countries including China, Argentina and Thailand. “The world knows by now that access to COVID-19 medical tools needs to be guaranteed for everyone, everywhere, if we really want to control this pandemic,” said Yuanqiong Hu, a senior legal policy adviser at Doctors Without Borders. The decisions by Pfizer and Merck to share their COVID-19 drug patents stands in stark contrast to the refusal of Pfizer and other vaccine-makers to release their vaccine recipes for wider production. A hub set up by the World Health Organization in South Africa intended to share messenger RNA vaccine recipes and technologies has not enticed a single pharmaceutical to join. Fewer than 1% of Pfizer’s COVID-19 shots have gone to poorer countries.
India's Everest Organics Ltd (EVER.BO) said on Tuesday it had started making the active pharmaceutical ingredient (API) for a generic version of Merck & Co's (MRK.N) experimental antiviral drug molnupiravir to treat mild to moderate COVID-19. According to Reuters, shares of Everest Organics jumped as much as 11.6% after the news came in, and were last up 9.9% at 330 rupees in a weak Mumbai market. Read: Moderna has no plans to share its COVID-19 vaccine recipe The Indian bulk drugs manufacturer joins Divi's Laboratories Ltd (DIVI.NS) as an API maker for Merck's experimental oral drug. Merck has separately entered into voluntary licensing agreements with at least eight Indian generic drugmakers for molnupiravir, with an aim to turn the country into a manufacturing hub for the drug. "After the successful development and commercialisation of various COVID-19 drugs such as Oseltamivir, Remdesivir... Everest Organics is on its path of expansion of this portfolio," Chief Executive Officer Srikakarlapudi Sirisha said in a statement. Merck said on Monday it had sought U.S. emergency use authorisation for the drug, putting molnupiravir on course to become the first oral antiviral medication for COVID-19. Read:Covid vaccine: India's Covaxin gets emergency use approval for kids aged 2-18 The U.S. authorisation application was based on data released earlier this month by Merck and partner Ridgeback Biotherapeutics. The data showed molnupiravir nearly halved the risk of hospitalisation or death in at-risk non-hospitalised patients with mild-to-moderate COVID-19.