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Intercept (ICPT) Provides Safety Guidelines For Ocaliva
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Intercept Pharmaceuticals, Inc. provided a statement on the recent safety and dosing issues for lead drug Ocaliva.
Ocaliva was approved in the United States in May 2016 (and subsequently in the European Union and Canada) for the treatment of patients with primary biliary cholangitis (PBC) with an inadequate response to or intolerant to the standard of care, UDCA.
The dose recommended for earlier stage PBC patients with no or mild hepatic impairment was 5 mg once daily, which was increased after three months to 10 mg once daily based on tolerability and treatment response. On the other hand, in late stage patients with moderate or severe hepatic impairment (Child Pugh B or C cirrhosis), recommended dosing starts at 5 mg once weekly, with the possibility to gradually increase to a maximum of 10 mg twice weekly.
However, there have been a few safety issues. Deaths have been reported in PBC patients with moderate or severe hepatic impairment (Child Pugh B or C cirrhosis).
Last week, shares of Intercept plunged after the FDA warned regarding the safety issues related with incorrect dosing. The FDA reported 19 deaths due to Ocaliva and stated that the drug may also affect the liver.
However, Intercept conducted an analysis and concluded that that these patients were prescribed once daily doses of Ocaliva, which is seven times higher than the recommended weekly dose. The analysis was conducted in consultation with the FDA. The company concluded that deaths occurred due to the overdosing of the drug.
Consequently, Intercept issued the Dear Healthcare Provider (DHCP) letter. Thereafter, the FDA issued their own safety communication to reinforce recommended label dosing. Intercept is also working with the FDA on further updates to Ocaliva’s label for safety purposes.
Nevertheless, the news gave a major blow to investors as Ocaliva is the company’s only approved drug and such side-effects will limit the sales potential.
Intercept is evaluating Ocaliva for other indications primary sclerosing cholangitis and non-alcoholic steatohepatitis. We note that Novartis AG (NVS - Free Report) and Gilead Sciences, Inc. (GILD - Free Report) too have FXR agonists in phase II or earlier stages of clinical or preclinical development that can be used to treat PBC, NASH and the other liver diseases.
Investors interested in the broader healthcare sector can consider Alexion Pharmaceuticals, Inc. for valuable returns.
4 Stocks to Watch after the Massive Equifax Hack
Cybersecurity stocks spiked on recent news of a data breach affecting 143 million Americans. But which stocks are the best buy candidates right now? And what does the future hold for the cybersecurity industry?
Equifax is just the most recent victim. Computer hacking and identity theft are more common than ever. Zacks has just released Cybersecurity! An Investor’s Guide to inform Zacks.com readers about this $170 billion/year space. More importantly, it highlights 4 cybersecurity picks with strong profit potential.
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Intercept (ICPT) Provides Safety Guidelines For Ocaliva
Intercept Pharmaceuticals, Inc. provided a statement on the recent safety and dosing issues for lead drug Ocaliva.
Ocaliva was approved in the United States in May 2016 (and subsequently in the European Union and Canada) for the treatment of patients with primary biliary cholangitis (PBC) with an inadequate response to or intolerant to the standard of care, UDCA.
The dose recommended for earlier stage PBC patients with no or mild hepatic impairment was 5 mg once daily, which was increased after three months to 10 mg once daily based on tolerability and treatment response. On the other hand, in late stage patients with moderate or severe hepatic impairment (Child Pugh B or C cirrhosis), recommended dosing starts at 5 mg once weekly, with the possibility to gradually increase to a maximum of 10 mg twice weekly.
However, there have been a few safety issues. Deaths have been reported in PBC patients with moderate or severe hepatic impairment (Child Pugh B or C cirrhosis).
Last week, shares of Intercept plunged after the FDA warned regarding the safety issues related with incorrect dosing. The FDA reported 19 deaths due to Ocaliva and stated that the drug may also affect the liver.
However, Intercept conducted an analysis and concluded that that these patients were prescribed once daily doses of Ocaliva, which is seven times higher than the recommended weekly dose. The analysis was conducted in consultation with the FDA. The company concluded that deaths occurred due to the overdosing of the drug.
Consequently, Intercept issued the Dear Healthcare Provider (DHCP) letter. Thereafter, the FDA issued their own safety communication to reinforce recommended label dosing. Intercept is also working with the FDA on further updates to Ocaliva’s label for safety purposes.
Nevertheless, the news gave a major blow to investors as Ocaliva is the company’s only approved drug and such side-effects will limit the sales potential.
Intercept is evaluating Ocaliva for other indications primary sclerosing cholangitis and non-alcoholic steatohepatitis. We note that Novartis AG (NVS - Free Report) and Gilead Sciences, Inc. (GILD - Free Report) too have FXR agonists in phase II or earlier stages of clinical or preclinical development that can be used to treat PBC, NASH and the other liver diseases.
Investors interested in the broader healthcare sector can consider Alexion Pharmaceuticals, Inc. for valuable returns.
4 Stocks to Watch after the Massive Equifax Hack
Cybersecurity stocks spiked on recent news of a data breach affecting 143 million Americans. But which stocks are the best buy candidates right now? And what does the future hold for the cybersecurity industry?
Equifax is just the most recent victim. Computer hacking and identity theft are more common than ever. Zacks has just released Cybersecurity! An Investor’s Guide to inform Zacks.com readers about this $170 billion/year space. More importantly, it highlights 4 cybersecurity picks with strong profit potential.
Get the new Investing Guide now>>