Merck Battles US Government, FDA Allows Chinese Drug Import to Combat Shortage

US: In the first legal challenge by a drugmaker against the Inflation Reduction Act (IRA), Merck has filed a lawsuit against the US government to halt Medicare from negotiating lower prices for prescription drugs. The US Food and Drug Administration (FDA) has granted permission to import an unapproved chemotherapy drug from China temporarily to alleviate a severe shortage of cancer drugs in the United States. Additionally, the FDA has fully approved Leqembi, the Alzheimer's drug from Eisai and Biogen, after addressing all safety concerns.

The has issued an import alert to Intas Pharma's manufacturing facility located near Ahmedabad, India. However, the drugmaker has been permitted to continue supplying 24 products that are currently in short supply within the United States. Additionally, the FDA has issued an Official Action Indicated (OAI) to Indoco Remedies' sterile facility situated in Goa, India. The European Commission has authorized GSK's respiratory syncytial virus (RSV) vaccine, Arexvy, for preventing lower respiratory tract disease in adults aged 60 and above following FDA approval. FDA staff reviewers have also concluded that Sanofi and AstraZeneca's experimental RSV therapy, nirsevimab, is safe and effective in preventing RSV infections in infants. Furthermore, the agency has granted approval to Lynparza, a drug developed by AstraZeneca and Merck, for treating patients with metastatic castration-resistant prostate cancer (mCRPC) whose tumors have BRCA mutations.

Merck has taken legal action against the US government in a bid to prevent Medicare from negotiating lower prescription drug prices under the Inflation Reduction Act (IRA), marking the first time a drugmaker has challenged the law. The pharmaceutical industry claims that the IRA will reduce profits and discourage investment in innovative therapies. Biogen CEO Chris Viehbacher has criticized the law, calling it "extortion," while Novartis CEO Vas Narasimhan described it as "draconian." The lawsuit argues that the program would compel drugmakers to negotiate prices below market rates, which would violate the Fifth Amendment of the US Constitution. The IRA, permitting Medicare to negotiate prices for a limited number of drugs, was signed into law last August.

Despite concerns over the safety of Eisai and Biogen's Alzheimer's drug, Leqembi, the FDA granted it accelerated approval in January. However, on Wednesday, data from a late-stage trial of Leqembi suggested that it provides significant benefits to patients and that safety concerns should not impede its chances of receiving traditional approval. Eisai's application for full approval is based on data demonstrating that Leqembi slowed cognitive decline in individuals with early-stage Alzheimer's by 27% compared to a placebo. A panel of external advisers will meet on Friday to review the application. Although the use of certain blood thinners with Leqembi has been associated with a risk of brain hemorrhage, the FDA staff believe that these risks can be effectively communicated in the drug's prescribing information.

To address the current shortage of cancer drugs in the US, the FDA has authorized the temporary importation of an unapproved chemotherapy drug from China. Qilu Pharmaceutical, a Chinese manufacturer of cisplatin injections, has received clearance from the agency to export the drug to the US market, despite not having FDA approval. Qilu is working with Apotex, based in Toronto, to distribute 50-mg cisplatin vials in the US. Cisplatin is commonly used in chemotherapy medication for treating various types of cancer, and there are currently shortages of 17 cancer drugs in the US. Richard Pazdur, the director of the FDA's Oncology Center, has attributed the shortage to the industry's failure to invest in expanding production capacity.

Intas Pharma's manufacturing facility near Ahmedabad, India, was issued with a Form 483 containing 11 observations by the FDA last December after it was found that employees had destroyed documents related to the plant's manufacturing practices. The FDA has now imposed an import alert on the same facility, which will prevent drugs manufactured there from being supplied to the US market. However, the alert does allow the drugmaker to continue supplying 24 products that are currently in short supply in the US, including injectables for cancer and infections, as well as tablets for sedation, kidney stones, hormones, and heart issues. Intas has stated that it is actively working to address the concerns raised by the FDA.

After conducting an inspection of Indoco Remedies' sterile facility in Goa (India) from February 20 to 28, the FDA issued a Form 483 with four observations in February. However, the agency has now taken further action against the site by issuing an Official Action Indicated (OAI). GSK's RSV vaccine, Arexvy, has been authorized by the European Commission for preventing lower respiratory tract disease in adults aged 60 and over. This marks the first authorization of an RSV vaccine in Europe, and GSK plans to launch it before the next RSV season. The EU authorization follows the FDA's approval of Arexvy approximately a month ago.

The FDA's staff reviewers have evaluated Sanofi and AstraZeneca's experimental RSV therapy, nirsevimab, and determined that it is effective and safe in preventing RSV infections in infants. According to the reviewers, clinical trials revealed a positive safety profile for the therapy. This development comes before an upcoming advisory committee meeting to review the drug's marketing application. In May, the FDA approved RSV vaccines from GSK and Pfizer.

The FDA has given the green light for AstraZeneca and Merck's Lynparza to be used in treating newly diagnosed advanced prostate cancer. This authorization permits the drug to be employed alongside Johnson & Johnson's Zytiga and a steroid for metastatic castration-resistant prostate cancer (mCRPC) patients whose tumors have BRCA mutations. In other news, AstraZeneca has announced that a study on its bleeding reversal drug Andexxa was ended prematurely after it achieved its efficacy endpoint during the planned interim analysis. Patients who received Andexxa while on blood thinners in the study experienced better bleeding control compared to those in the control group. The drug has received accelerated approval in the US and conditional approval in Switzerland, the EU, and the UK.