Date	Action
IND Chronology (#106,739)
11/13/2009	IND submitted by Pharmasset
8/11/2010	Fast-track status granted
8/18/2011	End-of-Phase II meeting with Pharmasset to discuss Phase III program
10/11/2011	End-of-Phase II meeting with Pharmasset to discuss Phase III CMC development program
1/17/2012	Gilead Sciences completes acquisition of Pharmasset
6/5/2012	End-of-Phase II meeting with Gilead; sponsor proposes broadening indication to include hepatitis C virus genotypes 1, 4, 5 and 6
10/17/2012	Type C teleconference; Gilead says it no longer plans to seek an indication for HCV treatment-naïve genotype 2/3 patients who are co-infected with HIV-1 in the original NDA but would include SVR4 data for 31 co-infected patients enrolled in PHOTON-1 through September 2012; company expects to submit sNDA to support an HIV/HCV co-infection indication following original NDA approval
3/14/2013	Pre-NDA meeting; Gilead agrees with FDA recommendation that longer treatment duration (16 weeks) would be more beneficial for genotype 3 patients; company references European Medicines Agency’s view that labeling would be similar to HIV drugs with broad indication statements, but FDA says the issue will be a topic for discussion during NDA review and the advisory committee meeting; agency expresses concern about amount of emerging data made public by sponsor and its impact on the advisory committee meeting and regulatory decision-making, and says it wants to avoid discussion at the advisory committee of data that have not been formally reviewed
NDA Chronology (#204,671)
4/6/2013	NDA submitted
4/8/2013	NDA received by FDA
6/7/2013	Filing communication designating NDA for priority review, setting PDUFA goal date of 12/8/2013
7/11/2013	FDA determines proposed proprietary name “Sovaldi” is unacceptable because it could be confused with another product under review
7/17/2013	Mid-cycle teleconference with Gilead; FDA says internal discussions ongoing about regulatory implications of proposed broader indication for sofosbuvir use in combination with other agents
7/22/2013	FDA grants “breakthrough therapy” designation for fixed-dose combination of sofosbuvir with ledipasvir, an NS5A inhibitor
8/2013	FDA conducts product active ingredient inspection at Gilead Ireland site and issues two Form 483 observations
8/7/2013	Teleconference to discuss next steps for proprietary name submission
8/16/2013	Gilead submits alternative proposed proprietary name
8/20/2013	Teleconference to discuss compliance issues identified by European regulators at a sofosbuvir active pharmaceutical ingredient manufacturing site; FDA tells Gilead it needs to decide whether to keep or withdraw the site from the NDA
8/27/2013	Teleconference to discuss proprietary name request
9/19/2013	Informational briefing for CDER director on sofosbuvir NDA status and related inspectional/cGMP issues
9/27/2013	In a teleconference, FDA requests submission of all available VALENCE and PHOTON-1 data and instructs Gilead to submit a “breakthrough therapy” designation request for sofosbuvir in combination with ribavirin for the treatment of chronic HCV patients with genotype 1, 2 and 3 infection
10/3/2013	FDA receives Gilead’s request for breakthrough therapy designation
10/3/2013	FDA issues late-cycle meeting background package
10/7/2013	CDER Medical Policy Council agrees with Division of Antiviral Products’ recommendation to grant breakthrough therapy designation request
10/9/2013	VALENCE and PHOTON-1 study reports and datasets submitted
10/10/2013	Late-cycle meeting; FDA says NDA cannot be approved with the noncompliant API site listed in the application based on issues discussed during the 8/20/2013 teleconference; Gilead says it would remove the site from the NDA and has increased API production at other facilities; Gilead will present VALENCE data at advisory committee but not information about PHOTON-1 because panelists were not screened for conflicts to discuss the co-infection trial, FDA says
10/25/2013	Antiviral Drugs Advisory Committee unanimously endorses approval of sofosbuvir in combination with ribavirin for treatment of chronic hepatitis C in adults with genotypes 2 and 3 infection, and in combination with pegylated interferon/ribavirin in treatment-naïve adults with genotypes 1 and 4 infection
10/29/2013	Teleconference with Gilead to discuss inspectional issues at Foster City, Calif., testing site and options to support an approval recommendation from the Office of Manufacturing and Product Quality; Gilead agrees to remove Foster City as drug product and drug substance release and stability testing site in the NDA due to cGMP deficiencies
10/31/2013	Foster City site removed from NDA
11/7/2013	FDA deems Gilead’s proposed alternative proprietary name acceptable
11/20/2013	In teleconference, FDA informs Gilead the proprietary name “Sovaldi” is acceptable
12/6/2013	NDA approved, two days ahead of goal date

Sovaldi Clinical Development

More from United States

More from North America