WHO expands cough syrup deaths probe; FDA rejects Lilly’s accelerated nod request for Alzheimer’s drug

By PharmaCompass

2023-01-26

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The World Health Organization (WHO) has expanded its probe into cough syrup deaths to four other nations, and has also found support from the FDA in the case.

The US Food and Drug Administration (FDA) has rejected Eli Lilly’s bid for an accelerated approval pathway for its experimental Alzheimer’s disease drug donanemab, citing insufficient data.

The US Department of Justice (DOJ) is conducting a criminal investigation into operations at Abbott Laboratories’ infant formula plant in Sturgis, Michigan.

Another Indian drugmaker got flagged this week – the FDA has issued a Form 483 with nine observations to Indoco Remedies’ solid oral formulation manufacturing facility in Goa, India.

Indian drugmaker Sun Pharma has inked a US$ 576 million deal to acquire US-based Concert Pharmaceuticals. And Takeda has entered into a potential US$ 1.13 billion drug licensing deal with Hong Kong-based Hutchmed.

The FDA has made public a series of emails exchanged between senior FDA officials that highlight concerns raised over the agency’s accelerated review and approval process for Pfizer’s Covid-19 vaccine, Comirnaty. And Merck has halted a late-stage trial of Keytruda in prostate cancer as the therapy didn’t prove to be effective.

FDA rejects Lilly’s bid for accelerated approval of its Alzheimer’s drug

The FDA has rejected Eli Lilly’s bid for an accelerated approval of its experimental Alzheimer’s disease drug donanemab – an antibody designed to remove amyloid protein plaques from the brains of people in early stages of the disease.

In its complete response letter, FDA said Lilly did not provide enough data from patients who were treated for at least a year. Lilly’s accelerated approval bid was based on a small mid-stage trial where patients were allowed to stop treatment once their amyloid was cleared.

The company expects data from a phase 3 trial of the drug in the second quarter of this year. Donanemab belongs to the same class of Alzheimer’s drug as Biogen and Eisai’s Leqembi (lecanemab) that received FDA approval earlier this month.

Meanwhile, Lilly is investing US$ 450 million to expand its facility in North Carolina’s Research Triangle, creating 100 new jobs. The expansion is slated to be completed in 2027.

WHO expands ‘deaths by cough syrup’ probe to four other nations; FDA extends support

The FDA is working with the WHO and other foreign regulatory authorities to support an investigation into the source of contamination in the cough syrups that have allegedly killed over 300 children in Africa and Asia, the agency said in a statement.

Earlier this week, the WHO had said it has expanded its investigation into contaminated cough syrups that were linked to deaths of children from acute kidney injury in Gambia, Indonesia and Uzbekistan to four additional countries — Cambodia, the Philippines, East Timor and Senegal – where the tainted cough syrups may have been sold. The agency has urged “immediate and concerted action” against contaminated medicines.

The WHO also said it is investigating a link between the manufacturers of these contaminated cough syrups. The agency is seeking more information about the specific raw materials that were used and whether they were obtained from any of the same suppliers. The WHO has identified six drugmakers in India and Indonesia who produced the syrups.

Abbott’s Michigan baby formula plant faces DOJ’s criminal probe: The US Department of Justice is conducting a criminal investigation into operations at Abbott Laboratories’ infant formula plant in Sturgis, Michigan, which was shut down last year after an FDA inspection found harmful bacteria and unsanitary conditions. The shutdown of the plant led to a nationwide shortage of baby formula. Meanwhile, Frank Gianna, FDA’s deputy commissioner for food policy and response has resigned, citing concerns about the agency’s oversight structure and the infant formula crisis.

India’s Indoco Remedies becomes latest recipient of FDA’s Form 483

The FDA recently issued Form 483s to several Indian drug manufacturers. This week, another Indian drugmaker – Indoco Remedies – became the latest recipient of FDA’s Form 483. It was issued with nine observations to Indoco’s solid oral formulation manufacturing facility (Plant 1) in Goa, India, after conducting an inspection from January 16 to 20.

Meanwhile, Torrent Pharmaceuticals said its Indrad facility in Gujarat, India, has received an Official Action Indicated (OAI) letter as part of an inspection that the FDA conducted last September that resulted in a Form 483 with three observations. An OAI implies that regulatory and/or administrative actions will be recommended.

Sun Pharma buys US-based Concert for US$ 576 million to gain its hair loss drug

Top Indian drugmaker Sun Pharma has inked a US$ 576 million cash deal to acquire US-based Concert Pharmaceuticals in order to gain access to its experimental drug for treating patchy baldness. This is the biggest deal by the Indian drugmaker since its US$ 3.2 billion acquisition of generic drugmaker Ranbaxy Laboratories in 2014. Concert’s lead candidate – deuruxolitinib – is being evaluated in a late-stage study as a treatment for alopecia areata, an autoimmune condition that results in patchy hair loss.

Japanese pharmaceutical company Takeda has entered into a potential US$ 1.13 billion licensing deal with Hong Kong-based Hutchmed to gain commercial rights to the latter’s colorectal cancer drug — fruquintinib — outside of China. Takeda will pay US$ 400 million upfront and up to US$ 730 million in potential milestone payments as part of the agreement.

FDA releases email exchange between officials over fast track approval of Comirnaty

The FDA has made public a series of emails exchanged between senior officials wherein concerns were raised about its accelerated review and the approval process for Pfizer’s Covid-19 vaccine, Comirnaty. The emails shed new light on the resignations of senior FDA officials in late 2021.

Marion Gruber, the director of the FDA’s Office of Vaccines Research and Review, had also questioned the effectiveness of booster vaccinations for healthy, younger adults. The 32-year FDA veteran and her deputy, Phil Krause, had left the agency in late 2021.

Merck halts Keytruda trial in prostate cancer as data shows lack of efficacy

Merck has halted a late-stage trial of its blockbuster immunotherapy drug Keytruda in prostate cancer after interim data showed the therapy did not extend survival or help improve patients’ lives without the disease worsening.

The phase 3 trial was testing Keytruda in combination with Xtandi and androgen deprivation therapy. This follows the drug’s failure in two other late-stage cancer trials – as a first-line therapy for liver cancer and as a later-line treatment for metastatic prostate cancer – last August.

While Keytruda experienced a setback in prostate cancer, the PD-1 inhibitor registered a win in a late-stage trial that may allow it to compete with AstraZeneca ’s Imfinzi for the treatment of a rare form of biliary tract cancer.

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