EMA Panel Backs Peanut Allergy Desensitizing Powder Palforzia

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) recommended on October 15 that marketing authorization be granted for Palforzia (Aimmune Therapeutics). The product is intended for desensitizing children and adolescents to peanut allergy.

Palforzia will be available as an oral powder in capsules (0.5, 1, 10, 20, and 100 mg) and as oral powder in sachet (300 mg). The active substance is defatted powder of Arachis hypogaea.

Through use of the product, children with a peanut allergy receive controlled exposure to precise, increasing amounts of peanut protein, mixed with soft food, every day. Over time, this may help to decrease their sensitivity to small amounts of peanuts.

According to the press release from the EMA, Palforzia can mitigate accidental exposure to small amounts of peanut protein. “[A] single dose of a least 1 gram of peanut protein would cause no more than mild allergy symptoms,” the EMA said.

The treatment is indicated for patients aged 4 to 17 years who have received a confirmed diagnosis of peanut allergy. Treatment may be continued for patients aged 18 years or older, according to the press release.

It should be administered under the supervision of a healthcare provider qualified in the diagnosis and treatment of allergic diseases and should be used in conjunction with a peanut-avoidant diet, the EMA notes.

The most common side effects that have been reported are abdominal pain, throat irritation, itch, nausea, vomiting, urticaria, and upper abdominal discomfort.

The next step in the approval process is to obtain market authorization from the European Commission. Detailed recommendations for use will be described in the summary of product characteristics, which will be published in the European public assessment report and will be made available throughout Europe.

“We are encouraged by the CHMP opinion, which recommends Palforzia as the first and only treatment option in the European Union for patients with peanut allergy and their families,” Andrew Oxtoby, president and chief executive officer of Aimmune Therapeutics, said in a statement. “Today’s decision underscores the strong and compelling data from our Palforzia clinical trials and follows the US FDA approval of Palforzia earlier this year. We look forward to the European Commission’s final decision for the marketing approval of Palforzia, which we expect later this year.”

The FDA said in granting its approval that patients, parents, or caregivers must be counseled on the need for always-available injectable epinephrine, the need for continued peanut avoidance, and on how to recognize signs of anaphylaxis.

Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune and and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick.

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Traditional Chinese medicine maker soars after top respiratory expert backs drug in potentially inhibiting coronavirus

a pile of food: Guangzhou Baiyunshan Pharmaceutical’s medicine made from Banlangen was found to be effective against the coronavirus in a series of in-vitro studies. Photo: Baidu

Guangzhou Baiyunshan Pharmaceutical’s medicine made from Banlangen was found to be effective against the coronavirus in a series of in-vitro studies. Photo: Baidu

Shares of a traditional Chinese medicine (TCM) company jumped after receiving validation from the nation’s top respiratory expert on its drug’s effect against the coronavirus, joining two other peers that have enjoyed huge gains this year.

Guangzhou Baiyunshan Pharmaceutical Holdings soared 13 per cent to HK$21.75 in Hong Kong and by 10 per cent to 34.18 yuan in Shanghai on Friday, after Zhong Nanshan, the public face of China’s fight against the Covid-19 pandemic, said one of its products could potentially inhibit the coronavirus.

Researchers led by Zhong found that Banlangen granules, a herbal medicine popular in China for treating common cold and flu, was effective against the virus in a series of in-vitro studies, Chinese newspaper Nanfang Daily quoted him as saying during a conference on Tuesday in Guangzhou. The drug was also widely used in the country during the 2003 severe acute respiratory syndrome (Sars) outbreak.

Get the latest insights and analysis from our Global Impact newsletter on the big stories originating in China.

Investors latched on to the hype surrounding the company even though the studies were still at an early stage and Zhong did not disclose whether or when any research paper or preclinical data will be published. The stock’s advance in Hong Kong marked its biggest daily jump since October 2018, while turnover ballooned 24 times to HK$240 million (US$31 million) from Thursday, according to Refinitiv data.

Zhong Nanshan smiling for the camera: Chinese respiratory specialist Zhong Nanshan said that one of Guangzhou Baiyunshan Pharmaceutical's products could potentially inhibit the coronavirus. Photo: Xinhua

© Provided by South China Morning Post
Chinese respiratory specialist Zhong Nanshan said that one of Guangzhou Baiyunshan Pharmaceutical’s products could potentially inhibit the coronavirus. Photo: Xinhua

Many pointed to the speculative nature of the surge on Friday. “In-vitro studies data is usually the weakest among preclinical data,” wrote Huang Jianping, general manager at asset management firm Shanghai Leader Capital, in a post published on online stocks forum Xueqiu.

Normally, pharmaceutical companies have to go through three phases of clinical trials on humans to establish the efficacy of the drugs, on top of evidence from animal experiments, he said. “If a Nasdaq-listed company said their drug was found to inhibit the virus in in-vitro studies, the company would be despised by the market.”

China relied heavily on traditional medicine to combat the virus earlier this year. Despite the government’s efforts to promote the use of such herbal remedies abroad, experts have warned that there is not enough evidence from clinical trials to establish their effectiveness.

Why it’s so hard for China to promote the use of traditional remedies abroad to treat Covid-19

And this is not the first time Zhong’s comments have contributed to a drug maker’s fortunes. Two Shenzhen-listed TCM companies, Shijiazhuang Yiling Pharmaceutical and Tianjin Chase Sun Pharmaceutical, reaped huge profits this year, after their drugs were included in the national standard therapy for Covid-19 patients and were recommended by Zhong.

Shares of Shijiazhuang Yiling have risen 94 per cent since a March

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