FDA Approves Gilead's Hepatitis C Drug - WSJ
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`HEALTH
`
`FDA Approves Gilead's Hepatitis C Drug
`Sovaldi Shown to Cure More Patients in Less Time
`
`Email
`
`Print
`
`1 Comment
`
`By JONATHAN D. ROCKOFF and JOSEPH C. WALKER
`Updated Dec. 6, 2013 6:53 p.m. ET
`
`The U.S. Food and Drug Administration approved on Friday a new treatment for
`hepatitis C infections that promises to cure more patients in a fraction of the time
`required by current therapies while giving Gilead Sciences Inc.
`a
`GILD +0.54%
`potential blockbuster.
`
`The drug, Sovaldi, is the first pill approved to treat some types of hepatitis C without
`interferon, an injected drug that can cause flulike symptoms.
`
`The hepatitis C virus is most often transmitted through the sharing of needles and
`other equipment used to inject drugs. More than three million Americans and about
`170 million world-wide are infected with the disease, which if untreated can lead to
`liver damage and death. The disease is the leading cause of liver transplants in many
`countries.
`
`The current treatment regimen of three drugs can require close to a year of injections
`which often cause side effects, and which don't work in a large number of patients,
`according to liver doctors.
`
`In clinical testing, Sovaldi was shown to cure about 90 % of patients when taken in
`combination with at least one other drug for 12 or 24 weeks, depending on the form of
`the disease they had. "It's a monstrous advance," said Douglas Dieterich, a liver
`specialist at Mount Sinai's Icahn School of Medicine in New York City who participated
`in the Sovaldi clinical testing.
`
`In clinical trials, the most commonly used regimens cured 60% or more of patients, but
`doctors say that in medical practice, the regimens are curing less than half of patients.
`
`Analysts estimate Sovaldi's annual sales could surpass $7 billion in several years,
`making it one of the biggest selling drugs in the world. But Gilead will face rivals,
`including AbbVie Inc.
`and Johnson & Johnson,
`which are
`ABBV +3.72%
`JNJ +0.57%
`also developing new hepatitis pills. Last month, the FDA approved a new hepatitis C
`pill from J&J called Olysio.
`
`Many patients have been holding off on treatment in anticipation of the drug's
`approval. "It is the kind of product that can launch to very high numbers," Gilead
`President John Milligan said in an interview. He said Gilead was prepared for "a mad
`rush."
`
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`Sovaldi will cost about $84,000 for patients with the most common form of hepatitis C
`taking a pill a day for 12 weeks, Gilead said. Dr. Milligan said he doesn't expect
`insurers will try to stymie use of the drug, although he anticipates that health plans will
`ask doctors to justify their prescription in writing before reimbursing, a process called
`prior authorization.
`
`VIDEO
`
`1
`
`Gilead 2003
`I-MAK v. Gilead
`IPR2018-00126
`
`11/10/2014
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`HEALTH
`
`FDA Approves Gilead's Hepatitis C Drug
`Sovaldi Shown to Cure More Patients in Less Time
`
`
`
`1 Comment
`
`By JONATHAN D. ROCKOFF and JOSEPH C. WALKER
`Updated Dec. 6, 2013 6:53 p.m. ET
`
`The U.S. Food and Drug Administration approved on Friday a new treatment for
`hepatitis C infections that promises to cure more patients in a fraction of the time
`required by current therapies while giving Gilead Sciences Inc.
`a
`GILD +0.54%
`potential blockbuster.
`
`The drug, Sovaldi, is the first pill approved to treat some types of hepatitis C without
`interferon, an injected drug that can cause flulike symptoms.
`
`The hepatitis C virus is most often transmitted through the sharing of needles and
`other equipment used to inject drugs. More than three million Americans and about
`170 million world-wide are infected with the disease, which if untreated can lead to
`liver damage and death. The disease is the leading cause of liver transplants in many
`countries.
`
`The current treatment regimen of three drugs can require close to a year of injections
`which often cause side effects, and which don't work in a large number of patients,
`according to liver doctors.
`
`In clinical testing, Sovaldi was shown to cure about 90 % of patients when taken in
`combination with at least one other drug for 12 or 24 weeks, depending on the form of
`the disease they had. "It's a monstrous advance," said Douglas Dieterich, a liver
`specialist at Mount Sinai's Icahn School of Medicine in New York City who participated
`in the Sovaldi clinical testing.
`
`In clinical trials, the most commonly used regimens cured 60% or more of patients, but
`doctors say that in medical practice, the regimens are curing less than half of patients.
`
`Analysts estimate Sovaldi's annual sales could surpass $7 billion in several years,
`making it one of the biggest selling drugs in the world. But Gilead will face rivals,
`including AbbVie Inc.
`and Johnson & Johnson,
`which are
`ABBV +3.72%
`JNJ +0.57%
`also developing new hepatitis pills. Last month, the FDA approved a new hepatitis C
`pill from J&J called Olysio.
`
`Many patients have been holding off on treatment in anticipation of the drug's
`approval. "It is the kind of product that can launch to very high numbers," Gilead
`President John Milligan said in an interview. He said Gilead was prepared for "a mad
`rush."
`
`What's This?
`
`Popular Now
`ARTICLES
`Can Money Buy
`Happiness? Here’s
`What Science Says
`
`1
`
`2
`
`3
`
`4
`
`5
`
`Opinion: Liberals
`Are Killing the
`Liberal Arts
`
`Estimated
`Enrollees for 2015
`Health Care
`Decrease
`
`Cloud Hangs
`Over Mexico First
`Lady’s House
`
`Obama Urges
`FCC to Protect Net
`Neutrality
`
`Sovaldi will cost about $84,000 for patients with the most common form of hepatitis C
`taking a pill a day for 12 weeks, Gilead said. Dr. Milligan said he doesn't expect
`insurers will try to stymie use of the drug, although he anticipates that health plans will
`ask doctors to justify their prescription in writing before reimbursing, a process called
`prior authorization.
`
`VIDEO
`
`1
`
`Gilead 2003
`I-MAK v. Gilead
`IPR2018-00126
`
`11/10/2014
`
`
`
`FDA Approves Gilead's Hepatitis C Drug - WSJ
`
`Page 2 of 3
`
`The drug is a so-called nucleotide analogue, or nuc, that blocks a protein needed by
`the hepatitis C virus to replicate.
`
`It was the crown jewel of Gilead's $11 billion purchase of Pharmasset in 2012. Gilead,
`of Foster City, Calif., paid a high, 90% premium to beat out rivals, but the drug gives
`the company an entree into a multibillion-dollar market that is rapidly growing as
`patients learn they have the disease and opt for treatments that are getting easier to
`take.
`
`Gilead is known for its treatments for HIV/AIDS, but it has been looking to diversify its
`portfolio.
`
`Many doctors and patients have been waiting for new hepatitis C drugs that can be
`taken without interferon injections.
`
`For the most common type of hepatitis C, known as Genotype 1, the FDA approved
`Sovaldi for use in combination with interferon and a pill called ribavirin. Gilead is still
`studying Sovaldi's use without interferon in Genotype 1 patients. Dr. Milligan said the
`results of these clinical trials will become available starting later this year.
`
`For two less common types of the virus, known as Genotypes 2 and 3, the FDA
`approved Sovaldi's use alongside ribavirin and without interferon.
`
`The FDA also approved Sovaldi's use in patients who are either awaiting a liver
`transplant or received one; these patients are vulnerable to fast-moving infections.
`
`Write to Jonathan D. Rockoff at jonathan.rockoff@wsj.com and Joseph Walker at
`joseph.walker@wsj.com
`
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`11/10/2014
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`
`
`FDA Approves Gilead's Hepatitis C Drug - WSJ
`
`Page 3 of 3
`
`Justin Hamlin
`
`Great! Expected, but definitely good news!
`
`Now if we can just get them to ban tattoos, we can make some headway against this disease.
`
`Dec 6, 2013
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